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MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.

Peter Gordon
Up to 21 years old
SITE00000965
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Inclusion Criteria:
All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following: >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology ARM C: Patient does not have any congenital long QT syndrome or congenital heart block ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib ARM D: Patient must be >= 2 years of age at the time of Late Callback ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation) NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Telomere disorders Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia Acute myeloid leukemia arising from myelodysplasia Therapy-related myeloid neoplasms Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) < 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) < 24%. *Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF >= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen Administration of prior anti-cancer therapy except as outlined below: Hydroxyurea All-trans retinoic acid (ATRA) Corticosteroids (any route) Intrathecal therapy given at diagnosis In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study 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 participation ARM D: Patient does not have any congenital long QT syndrome or congenital heart block
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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.

Christine Conelea
Not specified
This study is NOT accepting healthy volunteers
STUDY00010519
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Inclusion Criteria:

• 12-21 years old
• right-handed
• able to undergo MRI
• currently experiencing chronic motor and/or vocal tics
Exclusion Criteria:

• currently receiving therapy focused on tics
• currently taking neuroleptic/antipsychotic medications
Brain & Nervous System, Children's Health, Mental Health & Addiction
CBIT, TMS, Tourette's, neurodevelopmental disorders, tics, transcranial magnetic stimulation
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MT2019-41: A Phase 2 Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced with a Lentiviral Vector Carrying the FANCA Gene in Pediatric Subjects with Fanconi Anemia Subtype A

The objective of this study is to assess the therapeutic efficacy of a hematopoietic gene therapy consisting of autologous CD34+ enriched cells transduced with a LV carrying the FANCA gene in subjects with FA-A.

Margaret MacMillan, MD
1 year and over
STUDY00008719
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Inclusion Criteria:
Fanconi anemia as diagnosed by chromosomal fragility assay of cultured lymphocytes in the presence of DEB or a similar DNA-crosslinking agent Patients of the complementation group FA-A Minimum age: 1 year and a minimum weight of 8 kg At least 30 CD34+ cells/μL are determined in one bone marrow (BM) aspiration within 3 months prior to CD34+ cell collection OR (see subsequent criterion) If the number of CD34+ cells/ μL in BM is in the range of 10-29, peripheral blood (PB) parameters should meet two of the three following criteria: Hemoglobin: ≥11g/dL Neutrophils: ≥900 cells/μL Platelets: ≥60,000 cells/μL Provide informed consent in accordance with current legislation Women of childbearing age must have a negative urine pregnancy test at the baseline visit, and accept the use of an effective contraception method during participation in the trial
Exclusion Criteria:
Subjects with an available and medically eligible HLA-identical sibling donor. Evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities other than those reported as variant(s) of normal in BM aspirate analysis. This assessment should be made by valid studies conducted within the 3 months before the subject commences the stem cell mobilization/collection procedures of the clinical trial. Subjects with somatic mosaicism associated with stable or improved counts in all PB cell lineages. (If T-lymphocyte chromosomal fragility analysis indicates potential mosaicism, a medically significant decrease (≥1 NCI CTCAE grade) in at least one blood lineage over time must be documented to enable eligibility, as should <5% resistance of bone marrow colony forming cells (CFCs) to 10nM MMC; whenever possible potential mosaicism should also be evaluated by gene sequencing of MMC-resistant CFCs). Lansky performance status ≤60%. Any concomitant disease or condition that, in the opinion of the Principal Investigator, renders the subject unfit to participate in the study. Pre-existing sensory or motor impairment ≥grade 2 according to the criteria of the NCI. Pregnant or breastfeeding women. Hepatic dysfunction as defined by either: Bilirubin >3.0 × the upper limit of normal (ULN) or Alanine aminotransferase (ALT) > 5.0 × ULN or Aspartate aminotransferase (AST) > 5.0 × ULN For subjects with bilirubin, ALT or AST above ULN, a workup to identify the etiology of liver abnormality should be conducted prior to confirmation of eligibility as stipulated in exclusion criterion 5, including evaluation of viral hepatitis, iron overload, drug injury or other causes. Renal dysfunction requiring either hemodialysis or peritoneal dialysis. Pulmonary dysfunction as defined by either: Need for supplemental oxygen during the prior 2 weeks in absence of acute infection or Oxygen saturation by pulse oximetry <90%. Evidence of active metastatic or locoregionally advanced malignancy for which survival is anticipated to be less than 3 years. Subject is receiving androgens (i.e. danazol, oxymetholone). Subject is receiving other investigational therapy for treatment/prevention of FA-associated bone marrow failure.
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MT2020-06: A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF JSP191 FOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONING TO ACHIEVE ENGRAFTMENT AND IMMUNE RECONSTITUTION IN SUBJECTS WITH SCID

Phase 1: To evaluate the safety and tolerability of JSP191 and to determine Phase 2 doses of JSP191 as a conditioning agent prior to allogeneic hematopoietic cell transplantation (HCT) in two populations of subjects with severe combined immunodeficiency (SCID): • SCID subjects with history of prior allogeneic HCT but with poor graft function • SCID subjects who are HCT-naïve Phase 2: • To evaluate the efficacy of JSP191 conditioning to enable engraftment of allogeneic CD34+ hematopoietic cells, as determined by CD15+ donor myeloid chimerism • To evaluate the efficacy of JSP191 conditioning to enable immune reconstitution determined by the production of naïve T cells

Christen Ebens
3 month(s) and over
STUDY00010559
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Key
Inclusion Criteria:
All patient groups must have: Typical SCID as defined by Primary Immune Deficiency Treatment Consortia including but not limited to the following subtypes: T-, B+, NK-: IL-2Rcγ deficient, JAK3-deficient T-, B-, NK+: RAG1/2 deficient, Artemis-deficient T-, B+, NK+: IL7Rα deficient, CD3 subunit deficient, CD45 deficient OR Variant SCID with absent or low T cell function, Omenn syndrome, Leaky SCID, Reticular dysgenesis, Adenosine deaminase deficiency, and Purine nucleoside phosphorylase deficiency may be included after consultation with the medical monitor. Patients with human leukocyte antigen (HLA) matched related or unrelated donors Adequate end organ function as defined in study protocol Key
Exclusion Criteria:
Patients with any acute or uncontrolled infections Patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy Patients with active malignancies Active GVHD within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
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Identifying body awareness-related brain network changes during cognitive multisensory rehabilitation for reduced neuropathic pain in people with spinal cord injury

This mechanistic Phase II clinical trial will utilize a design with a standard parallel-arm RCT. Participants will be randomized into two groups. The Immediate Therapy Group will receive 6 weeks of CMR, 1-on-1, in-person, 3x/week, 45 min/sessions immediately, followed by 6 weeks of standard of care (no therapy) at home as a monitoring/observation period. And the Delayed Therapy Group will first complete the monitoring/observation period with 6 weeks of standard of care (no therapy) at home, followed by 6 weeks of CMR. The healthy group will not receive therapy. The baseline data obtained in the healthy control group will be compared with the baseline data and post-CMR data in both SCI groups.

Ann Van de Winckel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00008476
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Inclusion Criteria:

• spinal cord injury at least 3 months earlier
• medically stable with paraplegia and can self transfer with some assistance
• experiencing neuropathic pain
• healthy participants: sex and age matched, healthy and able bodied
Exclusion Criteria:

• unable to have a MRI due to seizures, cognitive impairment, or other major medical complications
Bone, Joint & Muscle, Brain & Nervous System
Neuropathic Pain, SCI, Spinal Cord Injury
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MT2020-08 A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in subjects with Relapsed/Refractory Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

Joseph Maakaron
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009953
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Inclusion Criteria:

• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
Exclusion Criteria:

• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
Cancer
Non-Hodgkin Lymphoma
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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy? System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
SITE00000818
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Inclusion Criteria:

• current diagnosis of major depression for at least two years or at least 4 episodes of major depression
• have an inadequate improvement in symptoms with at least 4 antidepressant treatments
• on at least one antidepressant with a stable drug schedule for at least 4 weeks
• history of other major mental health diagnosis (staff will review)
• treatment with another device or experimental drug
Exclusion Criteria:

• Currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
• acute suicide risk or suicide attempt within 6 months
• other psychiatric diagnosis, (staff will review)
Mental Health & Addiction
Depression, Major depression
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors&#13;&#10;for Stroke Prevention and Recovery (ASPIRE)

This study will compare the effects of apixaban with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Oladi Bentho
18 years and over
This study is NOT accepting healthy volunteers
SITE00000694
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Inclusion Criteria:

• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
Exclusion Criteria:

• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (?180 mm Hg)
• contact study staff for additional exclusion criteria
Brain & Nervous System, Heart & Vascular
Anticoagulation, Atrial Fibrillation (AF), CVA, ICH, Intracerebral Hemorrhage, Stroke
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A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors; Protocol Number: LOXO-RET-18036 (J2G-OX-JZJJ) (LIBRETTO-121)

This is an open-label, multi-center, Phase 1/2 study of oral LOXO-292 in pediatric patients with an activating RET alteration and an advanced solid or primary CNS tumor.

Emily Greengard
6 months to 21 years old
STUDY00008874
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Inclusion Criteria:
Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies Evidence of an activating RET gene alteration in the tumor and/or blood Measurable or non-measurable disease Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50 Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days Adequate hematologic, hepatic and renal function. Ability to receive study drug therapy orally or via gastric access Willingness of men and women of reproductive potential to observe conventional and effective birth control
Exclusion Criteria:
Major surgery within two weeks prior to planned start of LOXO-292 Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 Active uncontrolled systemic bacterial, viral, fungal or parasitic infection Clinically significant active malabsorption syndrome Pregnancy or lactation Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292) Uncontrolled symptomatic hypercalcemia or hypocalcemia Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s])
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OMS721-IGA-001: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

The purpose of this study is to test the safety and describe the effect of OMS721, an “investigational drug”, in people with IgA Nephropathy. OMS721 is being studied because it blocks a key enzyme (a protein that causes specific chemical changes in the body) in the blood that may be responsible for causing the damage in IgA Nephropathy. People are assigned by chance to receive either OMS721 or placebo, given via a 30-minute intravenous infusion (through a vein, also known as IV) once a week for 12 weeks.

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00002971
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Inclusion Criteria:

• age 18 years or older
• diagnosis of IgAN confirmed with biopsy no more than 8 years prior
• specific lab indicators of kidney function (study staff will review)
Exclusion Criteria:

• IgAN is being treated with immunosuppressants, cytotoxic drugs, eculizumab
• high blood pressure
• women who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug
• Type 1 diabetes mellitus
• history to kidney transplant
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), IgAN, Immunoglobulin A (IgA) Nephropathy, Kidney Disease, Renal Disease
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Comparison of normothermia maintenance between resistive blanket and forced air warming systems in renal transplant surgery

The purpose of the study is to compare the effectiveness of resistive blanket warming to forced air warming in maintaining body temperature in patients undergoing renal transplantation. Secondary outcome variables also include: • AUC of time versus temperature curves • temperatures at set points during operative period • Blood loss volumes

Cole Bennett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012072
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Inclusion Criteria:

• having a kidney transplant (not an emergency surgery)
Exclusion Criteria:

• previous organ transplantation or nephrectomy
• diagnosis of end stage renal disease with decreased or no urine output
• previous upper extremity amputation
• sepsis or other infection
• women who are pregnant
Kidney, Prostate & Urinary
Kidney transplant
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SKOAP: A Sequenced-Strategy for Improving Outcomes in people with knee OsteoArthritis Pain (SKOAP)

There is an urgent public health need to reduce our reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare recommended treatments to reduce pain and functional limitations in KOA and identify clinical and patient-level factors associated with treatment response. These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-opioid alternatives.

Clarence Shannon
18 years and over
This study is NOT accepting healthy volunteers
SITE00000944
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Inclusion Criteria:

• have osteoarthritis of a knee(s)
Exclusion Criteria:

• scheduled knee replacement surgery or history of knee replacement in the painful knee
• medical condition that prevents exercise
• untreated bleeding disorder
• ulcers or an open wound near the knee
Arthritis & Rheumatic Diseases
arthritis, knee pain, osteoarthritis
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MT2020-27: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This purpose of this study is to identify a safe dose level for the study drug, E7777, when given with standard tisagenlecleucel therapy (also known by its brand name, Kymriah, is an immunotherapy that is made from the participants own blood cells) in participants with Diffuse Large B-Cell Lymphoma (DLBCL). Up to three dose levels of E7777 will be tested.

Veronika Bachanova, MD
18 years and over
STUDY00011895
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Inclusion Criteria:
Diagnosis of a relapse or refractory (r/r) large B cell lymphoma, for which treatment with Kymriah is planned, including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma DLBCL arising from follicular lymphoma Considered at high risk for progression after CAR-T therapy by meeting one or more of the following factors: refractory to last line of therapy myc over expression >40% in any prior biopsy ≥2 sites of extranodal disease Received two or more lines of systemic therapy Has secured insurance coverage for Kymriah administration either in the outpatient or inpatient setting. Age 18 years or older at the time of signing consent. ECOG performance status of 0, 1, or 2 Adequate bone marrow reserve defined as: Absolute neutrophil count (ANC) > 1,000/mm^3 Platelets ≥ 50,000/mm^3 (transfusion support can be provided) Hemoglobin >8.0 mg/dl (transfusion support can be provided) Bone marrow involvement at disease assessment is an exclusion as these patients are at an increased risk of severe CRS and/or neurotoxicity Adequate organ function at enrollment and within 14 days of planned E7777 treatment including: renal function: eGFR ≥ 50 mL/min/1.73 m^2 liver function: ALT ≤ 3 times the upper limit of normal (ULN) for age, AST ≤ 3 times the ULN, total bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN (if liver is involved by lymphoma, the exception are allowed upon approval of PI) albumin ≥ 3.0 g/dl Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea (CTCAE v5) and pulse oxygenation SpO2 > 91% on room air. Pulmonary function tests within 28 days of enrollment: >50% corrected DLCO and FEV1 Hemodynamically stable and LVEF ≥ 50% confirmed by echocardiogram or MUGA Life expectancy ≥12 weeks in the opinion of the enrolling investigator as documented in the medical record Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use birth control for at least 30 days after study treatment or at least at least 4 months after the final dose of CY, whichever is longer Female participants: Two forms of birth control, one of which must be a barrier method, for example: use of intrauterine device (IUD) or oral contraceptives, plus a barrier method such as a condom, diaphragm or cervical cap Male participants: If possible to father a child (unless a successful vasectomy with confirmed azoospermia) participant and female partner, must use adequate contraception Written voluntary consent prior to the performance of any research related tests or procedures
Exclusion Criteria:
Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing) Known bone marrow involvement, if history of bone marrow involvement must have a BM biopsy to rule-out current involvement Prior allogeneic transplant Ocular disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an ophthalmological examine as part of screening Known CNS involvement by malignancy - if clinically suspicious, must be ruled-out by examination of cerebrospinal fluid (CSF) by flow cytometry Uncontrolled active hepatitis B or hepatitis C Active or inactive HIV infection Untreated active bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to enrollment) History of heart failure or pulmonary edema, evidence of pleural effusion or active lower extremity edema Uncontrolled unstable angina and/or myocardial infarction within 3 months of enrollment Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
Clinics and Surgery Center (CSC)
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Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial

To determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

James Flaherty
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009938
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Inclusion Criteria:

• undergoing one of the following elective or urgent (but not emergency) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
Exclusion Criteria:

• history of atrial fibrillation or flutter
• Infective endocarditis
• Left ventricular ejection fraction (LVEF) < 30%
• redo surgery
• unable to have a block because of local anesthetic allergy, bleeding problem
• Body mass index > 35kg/m2
• woman who is pregnant
Heart & Vascular
Clinics and Surgery Center (CSC), AF, Atrial Fibrillation, CABG, Cardiac Disease, Coronary Artery By-Pass Surgery
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Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use

The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA placed for procedures with duration greater than 1 hour.

Jacob Hutchins
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012614
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Inclusion Criteria:

• having outpatient ambulatory surgery
• receiving general anesthesia utilizing a laryngeal mask airway
• surgery expected to last longer than 1 hour
Exclusion Criteria:

• chronic laryngitis
• chronic bronchitis
• asthma
• gastroesophageal reflux disease
• smoked within the last week
• non-English speaking
Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), Anesthesia, Surgery
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A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.

Clark Chen
Not specified
This study is NOT accepting healthy volunteers
SITE00000958
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Inclusion Criteria:

• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Exclusion Criteria:

• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
Brain & Nervous System, Cancer
Brain Tumor
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A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of the Safety and Pharmacodynamic Activity of Gene Therapy for Congenital Adrenal Hyperplasia through Administration of an Adeno-associated Virus (AAV) Serotype 5-Based Recombinant Vector Encoding the Human CYP21A2 Gene

This is a study designed to evaluate the safety, tolerability, and efficacy of a one-time gene therapy (BBP-631) for adult patients diagnosed with classic congenital adrenal hyperplasia (CAH). The goal of gene therapy for CAH is to give the body a functioning CYP21A2 gene using a vector (an agent used to deliver a gene into the body). Having a functioning CYP21A2 gene in the adrenal gland may allow the body to naturally produce its own cortisol and aldosterone. The study treatment and follow-up lasts 1 year with a long-term follow-up of 4 more years.

Kyriakie Sarafoglou
18 years and over
STUDY00012144
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Key Inclusion Criteria Adult male and non-pregnant females with classic CAH (simple virilizing or salt-wasting) due to 21-OHD Screening/baseline 17-OHP levels > 5-10 × ULN and < 40 × ULN (upper limit of normal) Stable oral hydrocortisone (HC) regimen as the only glucocorticoid (GC) maintenance therapy Naïve to prior gene therapy or AAV-mediated therapy Key Exclusion Criteria Positive for anti-AAV5 (Adeno-Associated Virus Type 5) antibodies History of adrenalectomy and/or significant liver disease
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A Phase II, Open Label, Two Arm Study of Therapeutic Iobenguane (131I) as Single Agent or in Combination with Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects (OPTIMUM Trial) Protocol Number: MIBG 2014-01 (OPTIMUM)

This will be a Phase II, two-arm, nonrandomized, non-comparative, open-label study in participants ≥ 1 year of age with iobenguane avid, recurrent or progressive high-risk neuroblastoma. Participants not eligible for vorinostat treatment may receive 131I-MIBG as monotherapy.

Emily Greengard
1 year and over
STUDY00005792
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Inclusion Criteria:
Subjects with a diagnosis of iobenguane avid, high-risk neuroblastoma based on Revised INRC criteria at the time of study enrollment with recurrent or progressive disease at any time prior to enrollment, regardless of overall response to frontline therapy, where frontline therapy includes a minimum of 4 cycles of induction therapy at any time prior to enrollment. May have had prior 131I-MIBG therapy, provided: It has been at least 6 months from the date of last 131I-MIBG ; Response was other than progressive disease on first restaging after 131I-MIBG ; Prior 131I-MIBG was given as monotherapy and not in combination with systemic anticancer agents; Cumulative lifetime dose of 131I-MIBG at enrollment does not exceed 18 mCi/kg. All soft tissue lesions identified on CT/MRI scans must be iobenguane avid lesions on an (123I)-iobenguane scan, or any progressive non-iobenguane avid lesion is proven by biopsy to be a non-neuroblastoma lesion. any other non-avid lesion is comprised of a fibrotic or scarred mass as shown by routine imaging and confirmed by the investigator. Adequate cryopreserved autologous peripheral blood stem cells or bone marrow (at least 2 aliquots of 2.0 × 10exp6 CD34/kg at the time of study enrollment). If a male, must agree to use an adequate contraception method as deemed appropriate by the Investigator (e.g., vasectomy, condoms) or partner using effective contraception and to not donate sperm during the study and for 90 days after receiving the last dose of study drug. If a female of childbearing potential, have a negative serum pregnancy test result prior to each dosing and, if sexually active, be practicing an effective method of birth control [e.g., intrauterine device, double-barrier method (i.e., diaphragm, or a cervical cap) with intravaginal spermicidal foam, cream or gel], or male partner sterilization throughout the study. Age at study entry ≥1 year. Previous platelet transfusions are permitted, as long as the subject has a platelet count ≥50,000/μL without transfusion support for at least 1 week. Subjects must have a minimum pulse oximetry measurement of at least 94% at baseline. An absolute neutrophil count ≥750/μL without growth factor for 5 days. Liver function parameter results: total bilirubin ≤2 × upper limit of normal for age, and Serum alanine aminotransferase (glutamic-pyruvic transaminase) and serum aspartate aminotransferase (glutamic-oxaloacetic transaminase) ≤ 10 times the upper limit of normal (for all sites, the upper limit of normal for alanine aminotransferase is defined as 45 U/L). Normal thyroid function as measured by T4 or TSH or have abnormal results that are not considered clinically important by the Investigator or may be receiving levothyroxine. Cardiac Function: shortening fraction of ≥ 27% by echocardiogram or ejection fraction ≥ 50% documented by echocardiogram or radionuclide angiogram within 1 month prior to Visit 1 (Baseline). Karnofsky Performance Status (for subjects >16 years of age) or the Lansky Performance Status Performance Status (for subjects 1 to 16 years of age) ≥50%. Full recovery from the toxic effects of any prior therapy. Coagulation Function: International Normalized Ratio (INR) < 1.5 Partial thromboplastin time (PTT) < 1.5 times upper limit of normal.
Exclusion Criteria:
Subjects within 5 half-lives after any antibody-based immunotherapy, or have not recovered from effects of any biologic therapy. Subjects <12 weeks after myeloablative therapy with autologous stem cell transplant. Subjects who have had an allogeneic stem cell treatment less than 4 months from Visit 1 are excluded. Those who have received allogeneic stem cell treatment more than 4 months from Visit 1 must have recovered and have no active graft versus host disease (GVHD) to be eligible. Subjects must not have received radiation for a minimum of 2 weeks prior to study enrollment. Subjects whose only site(s) of disease have been radiated are eligible as long as the subject has MIBG avidity 2 weeks after completion of radiation. A minimum of 12 weeks prior to study enrollment is required following prior large field radiation therapy (ie, craniospinal, whole abdominal, total lung, > 50% marrow space) History of total body irradiation. Subjects do not have adequate renal function defined as GFR ≥ 70 mL/min/1.73 m2 either by creatinine clearance or radioisotope direct measurement or by calculation with the Schwartz formula Subjects who are on hemodialysis. Pregnancy or breastfeeding. Significant active infections including active hepatitis B, or hepatitis C infection, or known infection with human immunodeficiency virus (HIV) (testing for HIV is not required prior to study entry). Clinically important cardiac, pulmonary, and hepatic impairment. Vorinostat treatment exclusion criteria (subjects, who meet any one of these criteria and otherwise meet eligibility criteria, are still eligible for 131I-MIBG monotherapy) Since valproic acid has HDAC inhibitory activity, patients must not have received valproic acid within 30 days of study entry. Since vorinostat may prolong the QT interval, patients must not be receiving other medications known to prolong the QT interval at the time of study entry . Pentamidine must not have been received within 1 week of study enrollment. Patients with a history of deep venous thrombosis that was not associated with the presence of a central venous catheter. Patients who are receiving Coumadin.
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Brain Mechanisms of Qigong for Neuropathic Pain Relief in Adults with Spinal Cord Injury

The researchers aim to prove that Qigong practice can result in reduced or relieved neuropathic pain, improved mood, life satisfaction, self-efficacy, enjoyment to move, and community integration; and decreased fear of movement, use of medication or health care services for adults with spinal cord injury.

Ann Van de Winckel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011997
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Inclusion Criteria:

• 18 to 75 years old
• spinal cord injury (SCI) at least 3 months ago
• medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
• highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Exclusion Criteria:

• unable to have a MRI (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent the participant from following directions or from learning
• ventilator dependent
• pregnant or plans to become pregnant during study
• inability to perform kinesthetic imagery
Brain & Nervous System
SCI, Spinal Cord Injury
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Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa

The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).

Carol Peterson
18 years and over
This study is also accepting healthy volunteers
STUDY00010436
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Inclusion Criteria:

• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
Exclusion Criteria:

• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
Mental Health & Addiction
Bulimia Nervosa
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Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Greg Helmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013236
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Inclusion Criteria:

• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
Exclusion Criteria:

• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
Heart & Vascular
Clinics and Surgery Center (CSC), Dilated Cardiomyopathy, Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)

Electronic Platform for Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long&#8208;Acting Growth Hormone Therapy (LAuGH TRACK UMN) (LAuGH TRACK)

The purpose of the study is to compare quality of life (QOL), adherence, insulin resistance, body composition and efficacy of LAGH to DGH in children with GHD.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00011784
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Inclusion Criteria:

• girls ages 2-11 years
• boys ages 2-13 years
• established diagnosis of pediatric growth hormone deficiency (GHD).
• For this study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of <10 ng/mL Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance.
Exclusion Criteria:

• any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment
• current treatment with long-acting growth hormone
• currently pregnant or breastfeeding
Children's Health, Diabetes & Endocrine
Growth Hormone Deficiency
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Improving Spinal Cord Stimulation with ECAP

The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.

David Darrow
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013100
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Inclusion Criteria:

• medically stable as determined by the principal investigator
• scheduled to have external spinal cord stimulation
• English-speaking
Exclusion Criteria:

• scheduled for permanent implantation without an external trial
• have a pacemakers or other neurostimulators
• women who are pregnant
Bone, Joint & Muscle, Brain & Nervous System
Pain, Spinal Cord Stimulation
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Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients with EPI due to Chronic Pancreatitis (CP) (CisCP)

CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions

Guru Trikudanathan
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012592
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Inclusion Criteria:

• at least 18 years old
• history of chronic pancreatitis (CP).
• diagnosis of Exocrine Pancreatic Insufficiency (EPI)
Exclusion Criteria:
-history of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Exocrine Pancreatic Insufficiency (EPI)
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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naive Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Amit Kulkarni
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007800
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Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Cancer, Respiratory System
Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECT (RECONNECT)

The purpose of this study is to investigate how effective and safe ZYN002, a transdermal gel, is in participants with FXS. The drug product ZYN002 is a pharmaceutically manufactured CBD. It is being developed as a clear gel that can be applied to the skin (called transdermal delivery), to provide consistent, controlled levels of CBD in the blood when it is given twice a day. Participants will be assigned by chance to get one of the following study treatments: Active study drug – ZYN002 or placebo. Assigning study drug by chance is called “randomization,” and it is an important part of testing an experimental study drug. Participants will be randomly assigned to study treatment according to a computer program and will have 1 in 2 chance of receiving the active study drug.

Amy Esler
3 years to 23 years old
This study is NOT accepting healthy volunteers
SITE00001338
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Inclusion Criteria:

• ages 3 to less than 23 years
• resides with caregiver who will continue to provide consistent care throughout the study
• diagnosis of Fragile X Syndrome (FXS) through molecular documentation
• body mass index between 12-30 kg/m2
• in generally good health based upon the results of medical history, physical exam, 12-lead ECG and clinical laboratory test results
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant, nursing or planning a pregnancy
• has transitioned to independent living or living in a residential facility such as a university setting or congregate care
• use of cannabis or any THC or CBD-containing product within 3 months first study visit or during the study
• positive drug screen, including ethanol, cocaine, THC, barbiturates, amphetamines (unless prescribed), benzodiazepines (except midazolam or comparable administered for blood draws and ECG collection), and opiates
• additional medical or mental health diagnosis (study staff will review)
Rare Diseases
Fragile X Syndrome
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STUDY OF PHIL?? EMBOLIC SYSTEM IN THE TREATMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS (PHIL dAVF)

Arteriovenous fistulas are a type of arteriovenous malformation whereby blood is shunted directly from the arterial system to the venous system, bypassing the capillary bed. Dural arteriovenous fistulas (dAVFs) are a rare type of acquired intracranial vascular malformation consisting of a pathologic shunt located within the dura mater of the brain. 1 These lesions have been categorized by Awad et al 2, Borden et al 3, and Cognard et al 4 according to their locations and patterns of venous drainage. Dural arteriovenous fistulas (dAVFs) can be observed anywhere on the dural layer meninges of the cranium and spine. This condition accounts for 10-15% of all intracranial arteriovenous malformations diagnosed. 5 These fistulas can be congenital or acquired diseases. When observed as acquired diseases, they are most often encountered in males between the age of 50 and 60 years old. DAVFs present with a wide spectrum of symptoms or none at all, and come with varying range of risk of clinical sequalae. A thorough evaluation of the anatomy and venous drainage is crucial to determining the best treatment strategy. Acute presentation with intracranial hemorrhage occurs in up to 65% of patients, and patients with a previous intracranial hemorrhage may have up to a 35% risk of another neurologic event within 2 weeks. 6 Endovascular embolization has become the primary treatment approach for DAVFs. The goal of endovascular therapy is to achieve complete obliteration of the fistulous point between the feeding arteries and the draining veins. This can be safely accomplished by occluding the draining veins, which often results in complete closure of the lesion, unlike in cerebral arteriovenous malformations. The PHIL® device is a non-adhesive liquid embolic agent comprised of a Triiodophenol-(lactide-co-glycolide) acrylate and hydroxyethyl methacrylate (HEMA) co-polymer dissolved in DMSO (dimethyl sulfoxide). An iodine component is chemically bonded to the co-polymer to provide a radiopacifier element during fluoroscopic visualization. The PHIL® Liquid Embolic System consists of a sterile, pre-filled, 1.0 mL syringe of PHIL® liquid embolic, a sterile, prefilled 1.0 mL syringe of DMSO, and microcatheter hub adaptors. Intracranial dAVFs may produce a wide variety of symptoms. Individual risk is evaluated by a precise analysis of the venous drainage. The decision to treat is based on this analysis. Treatment strategy is decided by a multidisciplinary neurovascular team and must consider the individual risk of each dAVF. Embolization is, in most cases, proposed as the first treatment option and often succeeds to obtain a complete and definitive cure of the dAVF. Surgery may be required in some locations or in the case of embolization failure. Radiosurgery is rarely indicated because it is not always efficient and because of the time required for shunt obliteration and the risk of bleeding in this period. Liquid embolics have distinct characteristics that make them a principle treatment option in the obliteration of dAVFs. They can flow through complex vascular structures so that the surgeon does not need to target the catheter to every single vessel. 10 There is little choice available in the US market for the liquid embolic treatment of dAVF. Currently, nBCA (TRUFILL n-Butyl Cyanoacrylate, Cordis) and Onyx (Medtronic) are the only liquid embolic agents available. Both are approved by FDA for presurgical embolization of cerebral arteriovenous malformations. However, they have been used off-label for dAVFs. This use demonstrates the unmet medical need for the patients suffering with dAVFs. The aim of this study is to evaluate the use of PHIL in the management of intracranial dural AVFs.

Ramu Tummala
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003548
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Inclusion Criteria:

• 22 to 80 years old
• diagnosis of intracranial arteriovenous dural fistula (dAVF)
Exclusion Criteria:

• multiple dAVFs to be treated
• history of life threatening allergy to contrast media (unless treatment for allergy is tolerated)
• women who are pregnant
Brain & Nervous System
Arteriovenous Dural Fistula, dAVF
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An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Researchers want to find out more about how two programs may help adolescents with depression. Participants will be randomly assigned to one of two programs; the group will be decided by chance (like a flipping a coin). One group will have sixteen weeks of the clinic’s usual therapy: therapists will use the therapy procedures that they usually use. The other group will have twelve sessions of a therapy called interpersonal psychotherapy for depressed adolescents (IPT-A). IPT-A focuses on helping adolescents improve their relationships. Adolescents whose depression does not improve enough will either attend an additional four IPT-A sessions or they will be prescribed an antidepressant medication. The study will last about 36 weeks.

Meredith Gunlicks-Stoessel
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00000069
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Inclusion Criteria:

• 12 -18 years old
• currently experiencing significant symptoms of depression that are having an impact on ability to function
Exclusion Criteria:

• non English speaking
• actively suicidal
• diagnosed with other mental health problems such as anorexia, bipolar, substance abuse disorder, psychoses, autism disorder
• currently taking medication for a psychiatric disorder other than ADHD
Mental Health & Addiction
Adolescent, Depression
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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-55 years old with Medicare or Medicare Advantage insurance.

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006945
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Inclusion Criteria:

• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
Exclusion Criteria:

• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Mental Health & Addiction
Clinics and Surgery Center (CSC), Chronic Depression, Depression
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The efficacy of incobotulinum toxin A injections for treatment of tinnitus: a randomized controlled trial

This study is a double blinded crossover clinical trial evaluating the safety and effectiveness of incobotulinum toxin A or a placebo (before crossover) injections for the treatment of tinnitus.

Stephanie Standal
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011665
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Inclusion Criteria:

• unilateral or bilateral tinnitus present for at least 2 months
• score greater than 16 on the Tinnitus Handicap Inventory
Exclusion Criteria:

• known hypersensitivity to any botulinum toxin product
• received botulinum toxin for any medical reason in the past 4 months
• infection at proposed injection sites
• scheduled for neurological or otological surgery
• significant psychiatric history or associated diagnosis of major depression
• pregnant or breast feeding
Ear, Nose & Throat
Tinnitus
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