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297 Study Matches

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Nicole Hartung
Phase III
This study is NOT accepting healthy volunteers
NCT04457596
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Synchronous Bilateral Breast Carcinoma
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PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

PRI-VENT FSGS is a phase III, multicenter, randomized, open label, clinical trial to test the hypothesis that plasmapheresis plus rituximab prior to kidney transplantation can prevent recurrent FSGS in children and adults.

Priya Verghese
All
1 Year to 65 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03763643
STUDY00004388
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Age 1-65 years at the time of kidney transplant
• Biopsy proven diagnosis of primary FSGS or minimal change disease
• History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia)
• First kidney transplant or second or third transplant with a history of recurrent FSGS in the first or second kidney transplant.
• The patient (if ≥18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if <18 years old will be required per local IRB requirements.
• Negative urine pregnancy test prior to randomization (for females who are post-menarche).
• Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab. An individual who meets any of the following criteria will be excluded from participation in this study:
• Known genetic cause of FSGS 2. Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.) 3. 4. Received rituximab within 1 year prior to transplant 5. Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 7. Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.
• Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer) 9. ANC < 1.5 x 103 10. Hemoglobin: < 8.0 gm/dL 11. Platelets: < 100,000/mm 12. AST or ALT >2.5 x Upper Limit of Normal at the local institution's laboratory 13. History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.
• Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential 15. Concomitant malignancies or previous malignancies 16. History of psychiatric disorder that would interfere with normal participation in this protocol 17. History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease) 18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 19. Inability to comply with study and follow-up procedures
Drug: Rituximab, Procedure: Plasmapheresis
Focal Segmental Glomerulosclerosis
Clinics and Surgery Center (CSC)
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CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

All
12 Months to 29 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04145349
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Inclusion Criteria:

• Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose or per the type of previous treatment as stated in the protocol and must have recovered from the acute effects to ≤Grade 2 for alopecia and decreased tendon reflex and to ≤Grade 1 for all other effects at the time of enrollment, unless otherwise noted. Consult with the Lilly clinical research physician or scientist for the appropriate length of time prior to the first dose of study treatment.
• Participants with relapsed, recurrent, or refractory DSRCT.
• Participants must:
• Have measurable disease by Response Evaluation Criteria in Solid Tumors, Version (RECIST) 1.1.
• Have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy). This prior treatment must include approved therapies for which they are eligible, unless the participant is not a suitable candidate for the approved therapy.
• Not be eligible for surgical resection at time of enrollment.
• Adequate cardiac function, defined as: Shortening fraction of ≥27% by echocardiogram, or ejection fraction of ≥50% by gated radionuclide study.
• Adequate blood pressure (BP) control, defined as:
• Participants ≥18 years: Controlled hypertension defined as systolic BP ≤150 millimeters of mercury (mmHg) or diastolic BP ≤90 mmHg where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
• Participants <18 years: A BP ≤95th percentile for age, height, and gender measured as described in National High Blood Pressure Education Program Working Group (NHBPEPWG) on High Blood Pressure in Children and Adolescents (2004), where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
• Adequate hematologic function, as defined as:
• Absolute neutrophil count (ANC): ≥750/microliters (µL) granulocyte-colony stimulating factor (G-CSF) permitted up to 48 hours prior. Participants with documented history of benign ethnic neutropenia or other conditions could be considered with a lower ANC after discussion with and approval from the Lilly clinical research physician or scientist.
• Platelets: ≥75,000/cubic millimeters. Platelet transfusion permitted up to 72 hours prior.
• Hemoglobin: ≥8 grams per deciliter (g/dL) (≥80 g/liter). Transfusions to increase the participant's hemoglobin level to at least 8 g/dL are permitted; however, study treatment must not begin until 7 days after the transfusion, and complete blood count criteria for eligibility are confirmed within 24 hr of first study dose.
• Adequate renal function, as defined as:
• Creatinine clearance or radioscope glomerular filtration rate (GFR) ≥60 milliliters/minute/meters squared OR serum creatinine meeting the following parameters:
• for participants ≥18 years of age serum creatinine ≤1.5×upper limit of normal (ULN);
• for participants <18 years of age, serum creatinine based on age/gender as follows: Age 1 to <2 years maximum serum creatinine 0.6, Age 2 to <6 years maximum serum creatinine 0.8, Age 6 to <10 years maximum serum creatinine
• 0, Age 10 to <13 years maximum serum creatinine 1.2, Age 13 to <16 years maximum serum creatinine 1.5 for males and 1.4 for females, Age 16 to <18 years maximum serum creatinine 1.7 for males and 1.4 for females.
• Urine protein meeting the following parameters:
• for participants ≥18 years of age: <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
• for participants <18 years of age: ≤30 milligrams per deciliter urine analysis or <2+ on dipstick. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <1 g of protein in 24 hours to allow participation in the study.
• Adequate liver function:
• Total bilirubin: ≤1.5×ULN. Except participants with document history of Gilbert Syndrome who must have a total bilirubin level of <3.0×ULN.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): ≤2.5×ULN OR ≤5.0×ULN if the liver has tumor involvement.
• The participant has an adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5×ULN, and partial thromboplastin time ≤1.5×ULN if not receiving anticoagulation therapy. For participants receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use. Participants must have no history of clinically significant active bleeding (defined as within 14 days of first dose of study drug) or pathological condition that carries a high risk of bleeding (for example, tumor involving major vessels or known esophageal varices).
• The participant has adequate hematologic and organ function ≤1 week (7 days) prior to first dose of study drug.
• Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to randomization. Male and female participants must agree to use highly effective contraception for the duration of the study and up to 3 months following the last dose of ramucirumab and vinorelbine, and 12 months following the last dose of cyclophosphamide in order to prevent pregnancy.
Exclusion Criteria:

• Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
• Participants who have active infections requiring therapy.
• Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
• Participants who have had allogeneic bone marrow or solid organ transplant are excluded.
• Surgery: Participants who have had, or are planning to have, the following invasive procedures are not eligible:
• Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment.
• Central line placement or subcutaneous port placement is not considered major surgery.
• Core biopsy, fine needle aspirate, and bone marrow biopsy/aspirate are not considered major surgeries.
• Surgical or other wounds must be adequately healed prior to enrollment.
• Bleeding and thrombosis:
• Participants with evidence of active bleeding or a history of significant (≥Grade 3) bleeding event within 3 months prior to enrollment are not eligible.
• Participants with a bleeding diathesis or vasculitis are not eligible.
• Participants with known or prior history in the prior 3 months of esophageal varices are not eligible.
• Participants with a history of deep vein thrombosis requiring medical intervention (including pulmonary embolism) within 3 months prior to study enrollment are not eligible.
• Participants with a history of hemoptysis or other signs of pulmonary hemorrhage within 3 months prior to study enrollment are not eligible.
• Cardiac:
• Participants with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study enrollment are not eligible.
• Participants with myocardial infarction or unstable angina within the prior 6 months.
• Participants with New York Heart Association Grade 2 or greater congestive heart failure (CHF).
• Participants with serious and inadequately controlled cardiac arrhythmia.
• Participants with significant vascular disease (eg, aortic aneurysm, history of aortic dissection).
• Participants with clinically significant peripheral vascular disease.
• Participants who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment are not eligible.
• Participants with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible.
• Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment are not eligible.
• Participants previously treated and progressed on combination cyclophosphamide and vinorelbine regimen. Participants who received combination as maintenance therapy, without progression, would be eligible.
• Participants with a known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine or any of the excipients of the medicinal products.
• Hepatic impairment:
• Severe liver cirrhosis Child-Pugh Class B (or worse).
• Cirrhosis with a history of hepatic encephalopathy.
• Clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
• History of hepatorenal syndrome.
• The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (eg, hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
• The participant has a urinary outflow obstruction.
• The participant has Grade 2 hematuria or non-infectious cystitis at the time of screening.
• Participants with central nervous system (CNS) involvement are ineligible.
Drug: Ramucirumab, Drug: Cyclophosphamide, Drug: Vinorelbine
Desmoplastic Small Round Cell Tumor
soft tissue sarcoma, adolescents and young adults (AYAs), adolescent
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Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

ACURATE IDE is a prospective, multicenter trial designed to evaluate the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for TAVR in subjects who have severe native aortic stenosis and are indicated for TAVR. Study cohorts include the following: 􀁸 Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus Control [commercially available SAPIEN 3 or CoreValve] TAVR device). Randomization will be stratified by center and by intended control device. 􀁸 Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Symetis SA, Ecublens, Switzerland) will perform at least 2 roll-in cases before commencing enrollment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.

Mudassar Ahmed
Pivotal
This study is NOT accepting healthy volunteers
NCT03735667
STUDY00007377
Aortic Stenosis
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MT2016-15 :Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies

This is a two stage phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using a reduced intensity conditioning (cyclophosphamide, fludarabine, melphalan, total body irradiation) with modifications based on factors including age and comorbidities. Bone marrow is the donor graft source. This study is designed to estimate disease-free survival (DFS) at 1 year posttransplant. Since the goal is to estimate the DFS at a long-term time-point (1 year post-transplant), the design is a generalization of the Simon design. Rather than suspension of the trial for evaluation after stage 1, this design uses an optimal interim analysis for futility without suspension of accrual.

Najla El Jurdi
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02988466
1610M96901
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Inclusion Criteria:

• Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
• A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
• The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
• Adequate liver and renal function
• Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
• Diffusion capacity corrected (DLCOcorr) > 40% predicted, and absence of O2 requirements
• > 6 months after prior autologous transplant (if applicable)
• Agrees to use contraception during study treatment
• Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
• Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Exclusion Criteria:

• < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
• Pregnancy or breastfeeding
• Current active and uncontrolled serious infection
• Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
• CML in blast crisis
• Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
• stable non-bulky disease is acceptable.
• Active central nervous system malignancy Criteria For Donor Selection:
• Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
• Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
• For donors <18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors <18 years.
Biological: Haplo HCT <55 years old, Biological: Haplo HCT ≥55 years old, Drug: GVHD Prophylaxis, Biological: Haplo HCT ≥55 and < 65 years old, Biological: Haplo HCT ≥65 and ≤75 years old
Hematologic Malignancies
Acute Leukemias, Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL)/lymphoma, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, Myelodysplastic syndrome, Chronic myelogenous leukemia, Minimal Residual Disease (MRD) positive leukemia, Leukemia or Myelodysplastic Syndromes (MDS) in aplasia, Myeloproliferative neoplasms/myelofibrosis, Relapsed large-cell lymphoma, mantle-cell lymphoma and Hodgkin lymphoma, Burkitt's lymphoma, Relapsed T-cell lymphoma, Natural Killer cell malignancies, Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, Lymphoplasmacytic lymphoma, Relapsed multiple myeloma, Bone marrow failure syndromes, Clinics and Surgery Center (CSC)
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Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial

This phase III trial compares rose geranium in sesame oil nasal spray to isotonic nasal saline in improving symptoms of nasal vestibulitis in cancer patients receiving chemotherapy. Nasal (nose) symptoms (dryness, discomfort, bleeding, scabbing or sores) due to inflammation, termed nasal vestibulitis, is reported as a side effect of cancer-directed therapy. Rose geranium in sesame oil nasal spray may work better than isotonic nasal saline in improving symptoms of nasal vestibulitis.

Charles Loprinzi, M.D.
Phase III
This study is NOT accepting healthy volunteers
NCT04620369
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Nasal Vestibulitis
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Type 1 Diabetes Extension Study (T1DES)

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

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

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

• Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
• Inability to comply with the study visit schedule and required assessments.
Type 1 Diabetes Mellitus, T1DM, T1D
Insulin, Glucose Intolerance
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Dried Blood Spot Testing of CMV Detection in HCT Recipients

Subject-Collected Dried Blood Spot CMV Testing to Optimize Preemptive Therapy Late After Allogeneic HCT

Jo-Anne Young, MD
All
15 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03910478
STUDY00005408
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Inclusion Criteria:
Randomized Cohort:
• Must be >/= 15 years of age at the time of enrollment
• Must be able to provide written consent and complete the informed consent
• Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
• Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive
• One or both of the following:
• CMV event* within the first 100 days post-transplant requiring anti-viral treatment
• Receipt of CMV prophylaxis**(for at least 30 days) prior to randomization. Continuation of letermovir prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as deoxyribonucleic acid (DNA) detection or disease ** Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, or letermovir
• Direct availability to the internet either by a computer in the residence or a smart phone
• Had at least one or more of these conditions:
• HLA mismatch*
• umbilical cord blood source**
• Graft versus host disease (GVHD)***
• T-cell depletion**** * Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1
• Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for gastrointestinal (GI) GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment
• Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab Observation Cohort:
• Must be >/= 15 years of age at the time of enrollment
• Must have one of the following:
• Consented for retrospective studies at their transplant center, or
• Be included under the auspices of the site's IRB approved waiver of additional consent for retrospective studies
• Must have received allogeneic hematopoietic cell transplantation within 360 days prior to enrollment
• CMV seropositive or had a donor who was CMV positive
• One or both of the following:
• CMV event* within the first 100 days post-transplant requiring anti-viral treatment
• Receipt of CMV prophylaxis**(for at least 30 days) prior to registration. Continuation of letermovir prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as DNA detection or disease ** Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, or letermovir
• Meet at least one or more of criteria of the following:
• HLA mismatch*
• umbilical cord blood source**
• GVHD***
• T-cell depletion****
• Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1 **Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for GI GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment ****Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab
Exclusion Criteria:
Randomized Cohort:
• Inability to fully comprehend the study website and study procedures
• Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration Observational Cohort:
• Did not meet all inclusion criteria
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration
Device: DBS Self-Collection Kit, Other: Standard Control Strategy
Cytomegalovirus Infection
Allogeneic, Cytomegalovirus, Dried Blood Spot, Hematopoietic cell transplantation
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MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

Christen Ebens
All
up to 50 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01652092
1207M17321
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Inclusion Criteria:

• Diagnosis of immunodeficiency or histiocytic disorder including the following:
• Severe combined immunodeficiency (SCID - all variants)
• Second bone marrow transplant (BMT) for SCID (after graft rejection)
• Omenn's Syndrome
• Reticular dysgenesis
• Wiskott-Aldrich syndrome
• Major histocompatibility complex (MHC) Class II deficiency (bare lymphocyte syndrome)
• Hyper IgM Syndrome (CD40 Ligand Deficiency)
• Common variable immunodeficiency (CVID) with severe phenotype
• Chronic Granulomatous Disease (CGD)
• Other severe Combined Immune Deficiencies (CID)
• Hemophagocytic Lymphohistiocytosis (HLH)
• X-linked Lymphoproliferative Disease (XLP)
• Chediak-Higashi Syndrome (CHS)
• Griscelli Syndrome
• Langerhans Cell Histiocytosis (LCH)
• Acceptable stem cell sources include:
• HLA identical or 1 antigen matched sibling donor eligible to donate bone marrow
• HLA identical or up to a 1 antigen mismatched unrelated BM donor
• Sibling donor cord blood with acceptable HLA match and cell dose as per current institutional standards
• Single unrelated umbilical cord blood unit with 0-2 antigen mismatch and minimum cell dose of >5 x 10^7 nucleated cells/kg as per current institutional guidelines
• Double unrelated umbilical cord blood units that are:
• up to 2 antigen mismatched to the patient
• up to 2 antigen mismatched to each other
• minimum cell dose of at least one single unit must be ≥ 3.5 x 10^7 nucleated cells/kg
• combined dose of both units must provide a total cell dose of ≥ 5 x 10^7 nucleated cells/kg
• Age: 0 to 50 years
• Adequate organ function and performance status. Exclusion Criteria
• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Drug: Alemtuzumab 0.3 mg, Drug: Cyclophosphamide, Drug: Busulfan, Biological: Stem Cell Transplantation, Drug: Fludarabine phosphate 40 mg, Drug: Melphalan, Drug: Alemtuzumab 0.2 mg, Drug: Busulfan, Drug: Fludarabine phosphate 30 mg, Drug: MESNA
SCID, Omenn's Syndrome, Reticular Dysgenesis, Wiskott-Aldrich Syndrome, Bare Lymphocyte Syndrome, Common Variable Immunodeficiency, Chronic Granulomatous Disease, CD40 Ligand Deficiency, Hyper IgM Syndrome, X-linked Lymphoproliferative Disease, Hemophagocytic Lymphohistiocytosis, Griscelli Syndrome, Chediak-Higashi Syndrome, Langerhan's Cell Histiocytosis
immunodeficiency disorder, histiocytic disorder, Clinics and Surgery Center (CSC)
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Stratifying Patient Immune Endotypes in Sepsis (SPIES Study)

3.1 Primary Endpoint/Event/Outcome: To determine if stimulated T cell production of IFN-γ and stimulated monocyte production of TNFα as quantitated by ELISpot, better predicts important clinical metrics of impaired immunity in patients with sepsis than commonly used protein and nucleic acid measures of immune endotype.

Thomas Griffith
18 Years and over
NA
This study is also accepting healthy volunteers
URO-2021-29535
STUDY00011947
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Inclusion Criteria:

• All adults (age ?18)
• Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria:

• Current, chronic steroid use
• Pregnancy
• Current or recent (within 7 days) use of antibiotics.
Immune Diseases
Sepsis
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Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

Sugars, which are present naturally in some tobacco types and are also added to cigarette tobacco filler as additives, are may contribute to the harmful properties of cigarettes in three critical ways: by enhancing smoke palatability and appeal and, as precursors to aldehydes and other constituents in the smoke, by increasing smoke toxicity and carcinogenicity and potentially addictiveness. The overall goal of our research is to provide the U.S. FDA with the scientific basis to determine whether sugars should be added to the list of harmful and potentially harmful constituents (HPHC) list and whether their levels in tobacco products should be regulated. In this particular study, we will investigate the impact of sugar content in cigarette tobacco on cigarette abuse liability and appeal. To achieve this goal, we will conduct a laboratory study in which smokers of cigarettes with medium sugar content will smoke study cigarettes with differing levels of sugars in a laboratory setting. To prepare cigarettes, we will add a mixture of sucrose, glucose, and fructose to cigarettes that have low sugar content to match median and highest levels of sugars found in other commercial brands. Subjective and behavioral measures assessing abuse liability, sensory measures, and smoking topography will be compared across cigarettes with low (original), medium, and high sugar content.

Irina Stepanov
18 Years and over
NA
This study is also accepting healthy volunteers
2020LS236
STUDY00011825
Community Health, Prevention & Wellness
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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

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
All
2 Years to 5 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02735473
1506M74642
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Inclusion Criteria:

• Ages 2 years to 5 years of age
• Available parent or legal guardian capable of giving informed consent for participation.
• Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
• Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005).
Exclusion Criteria:

• Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
• Known history of a medical condition known to affect brain function.
• Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
• Known history of very low birthweight (<1500 grams)
Drug: Choline bitartrate, Drug: Placebo
Fetal Alcohol Spectrum Disorders
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Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

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

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

• Emergency procedures
• Condition/procedure that requires planned airway control via endotracheal tube or LMA/IGEL insertion
• Cranio-facial malformation, which would severely limit the possibilities for emergency airway rescue
• Other abnormalities relating to the airway (including large tonsils and anatomical abnormalities of upper airway or lower airway) which may compromise emergency airway rescue
• Known hypersensitivity to benzodiazepines, flumazenil, dextran or any of the ingredients of the drug product
• Known paradoxical reactions to benzodiazepines
• History of sleep apnoea
• Active respiratory failure
• Active neuromuscular disease
• Active cardiac failure
• Active hepatic failure
• Breast feeding females
• Prohibited medication
• Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason
Drug: Remimazolam
Pediatric ALL
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A RANDOMIZED PHASE III STUDY OF IBRUTINIB PLUS OBINUTUZUMAB VERSUS IBRUTINIB PLUS VENETOCLAX AND OBINUTUZUMAB IN UNTREATED OLDER PATIENTS (&#8805; 70 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Birendra Kumar
Phase III
This study is NOT accepting healthy volunteers
NCT03737981
0123456789
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysm

The primary objective of this research project is development and validation of a new, non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic aneurysm in the chest and abdomen in at risk patients. This study would initially be performed in patients with a known aneurysm and done in addition to their indicated surveillance CT scan.

Rumi Faizer
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT03479164
1510M79442
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Inclusion Criteria:

• Adult patients who carry the diagnosis of thoracic aortic aneurysm, aortic dissection, or abdominal aortic aneurysm and require CT imaging to evaluate the pathology
Exclusion Criteria:

• Current pregnancy
Other: Ultra Low-Dose CT
Aortic Aneurysm, Thoracic, Aortic Aneurysm, Abdominal
Clinics and Surgery Center (CSC)
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Corrona Inflammatory Bowel Disease (IBD) Registry

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

Byron Vaughn
NA
This study is NOT accepting healthy volunteers
NCT03162549
STUDY00007736
Inflammatory Bowel Diseases
Clinics and Surgery Center (CSC)
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EPI-MINN: Targeting Cognition and Motivation

All
15 Years to 40 Years old
N/A
This study is NOT accepting healthy volunteers
NCT05112432
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Inclusion Criteria:

• Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
• Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)
• Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication)
• Has access to a smartphone or other mobile device to use the PRIME app
Exclusion Criteria:

• Under legal commitment to treatment or is under medical guardianship, and there is no provision in the guardianship order or a court order to allow the guardian to consent to participation in research
• Participated in significant cognitive training programs within the last three years
• Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed)
• Clinically significant substance abuse that is impeding the participant's abulity to participate fully during recruitment, enrollment, assessment, or training, (is unable to remain sober for assessments and training)
• Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as:
• Active suicidal ideation at screening or baseline, or
• Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months
Other: Cognitive and Social Cognitive Training, Device: Personalized Real-Time Motivational Enhancement (PRIME) App
Psychosis
Cognitive Training, Motivation Enhancement, First Episode Psychosis, Schizophrenia Spectrum Disorders
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Characterization of spleen motion and anatomy using imaging and sensors

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

Hubert Lim
NA
ENT-2021-29988
STUDY00013252
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A person-centered employment preparation program for adolescents and young adults with autism spectrum disorder and their families

This study includes the development and evaluation of a person-centered employment preparation program for families of transition-aged youth with autism.

Rebekah Hudock
NA
PEDS-2021-30175
STUDY00013507
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Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribe meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Aaron Kelly
All
12 Years to 18 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04298203
STUDY00008743
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Inclusion Criteria:

• Severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• Age 12 to < 18 years of age at enrollment (screening) and Tanner stage >/= 2 - Female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:

• Diabetes (type 1 or 2)
• Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
• Previous metabolic/bariatric surgery
• Current use of a stimulant medication
• History of glaucoma
• Current or recent (<14 days) use of monoamine oxidase inhibitor
• Known hypersensitivity to sympathomimetic amines
• Any history of treatment with growth hormone
• Any history of bulimia nervosa
• Major psychiatric disorder as determined by the local medical monitor
• Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression
• Any history of active suicide attempt
• History of suicidal ideation or self-harm within the previous 30 days
• PHQ-9 score >15
• Current pregnancy or plans to become pregnant during study participation
• Current tobacco use
• ALT or AST >/= 3 times the upper limit of normal
• Bicarbonate <18 mmol/L
• Creatinine > 1.2 mg/dL
• Any history of seizures
• Uncontrolled hypertension as determined by the local medical monitor
• History of structural heart defect or clinically significant arrhythmia
• Diagnosed monogenic obesity
• Any history of cholelithiasis
• Any history of nephrolithiasis
• Clinically diagnosed hyperthyroidism
• Untreated thyroid disorder
• Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
Drug: Phentermine-Topiramate, Dietary Supplement: Meal Replacement Therapy, Other: Placebo
Obesity
Childhood, Adolescent, Clinics and Surgery Center (CSC)
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis

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

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

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

• Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
• Organ transplantation
• new diagnosis of CFRD in the past 6 months
• antidiabetic treatment in past 6 mos (insulin or oral hypoglycemic agents) -patients with previous CFRD diagnosis, but not currently taking insulin/glucose-lowering medications for at least 6 months should be included
• pulmonary exacerbation associated with systemic steroid requirement in the last 6 months
• on CFTR corrector less than 6 months prior to enrollment
Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Continuous glucose monitoring, Diagnostic Test: Dexa scan
Cystic Fibrosis-related Diabetes
cystic fibrosis, insulin, glucose, children, abnormal glucose tolerance, impaired glucose tolerance, indeterminate glycemia, diabetes
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A RANDOMIZED PHASE II/III OPEN-LABEL STUDY OF IPILIMUMAB AND NIVOLUMAB VERSUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MGMT (TUMOR O-6-METHYLGUANINE DNA METHYLTRANSFERASE) UNMETHYLATED GLIOBLASTOMA

Elizabeth Neil
Phase II/III
This study is NOT accepting healthy volunteers
NCT04396860
0123456789
Gliosarcoma, MGMT-Unmethylated Glioblastoma
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New biomonitoring methodologies to measure DNA adducts in urinary cells

Tobacco smoking and the consumption of well-done cooked meats are considered risk factors for bladder cancer. However, exactly how these exposures contribute to bladder cancer is still mostly unknown. The purpose of this pilot study is to evaluate the potential of urine to serve as a biospecimen for the analysis of cancer biomarkers. Participants will be asked to collect their urine from when they first wake up until 6 hours afterward.

Robert Turesky
NA
This study is also accepting healthy volunteers
2016NTLS094
1605M87561
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Inclusion Criteria:

• Daily Smoker
• 21 years of age or older
• In general good health
• Willing to collect urine for 6 hours
Exclusion Criteria:

• Unstable health condition
• Pregnant or nursing
Prevention & Wellness
cigarette, nicotine, smoking, tobacco
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MT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell Infusions

Jakub Tolar, MD
All
up to 25 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02582775
1510M79481
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Inclusion Criteria:

• Diagnosis of severe form of EB characterized by collagen, laminin, integrin, keratin or plakin deficiency (by immunofluorescence staining with protein specific antibodies or Western blotting and by mutation analysis).
• Adequate organ function within 4 weeks of study registration defined as:
• Renal: glomerular filtration rate within normal range for age
• Hepatic: Hepatic: bilirubin, AST/ALT, ALP < 5 x upper limit of normal
• Pulmonary: adequate pulmonary function in the opinion of the enrolling investigator
• Cardiac: left ventricular ejection fraction ≥ 45%, normal EKG or approved by Cardiology for transplant
• Sexually active participants must agree to use adequate birth control for the during the study period (from before the start of the preparative chemotherapy through 1 year post-transplant)
• Available donor per section 5: targeted MFI < 1,000 (MFI exceeding 1000 must be approved by the PI and treatment team.)
• Voluntary written consent - adult or parent (with information sheet for minors, if applicable) prior to any research related procedures or treatment
Exclusion Criteria:

• beta 3 laminin JEB mutants
• Active untreated systemic infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)
• History of HIV infection
• Evidence of squamous cell carcinoma
• Pregnant or breast feeding. Females of child-bearing potential must have a negative pregnancy test prior to study registration as the agents administered in this study are Pregnancy Category C and D.
Drug: Thymoglobulin, Drug: Cyclophosphamide, Drug: Fludarabine, Radiation: Total Body Irradiation, Procedure: Bone marrow infusion, Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Biological: Donor mesenchymal stem cell infusions, Drug: Busulfan
Epidermolysis Bullosa
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MT2013-34C: Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia: Standard of Care Considerations

Christen Ebens
All
up to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02162420
1404M50183
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Inclusion Criteria:

• Aged 0 - 70 years
• Acceptable hematopoeitic stem cell donor
• Dyskeratosis Congenita (DC) with evidence of BM failure defined as:
• requirement for red blood cell and/or platelet transfusions or
• requirement for G-CSF or GM-CSF or erythropoietin or
• refractory cytopenias having one of the following three
• platelets <50,000/uL or transfusion dependent
• absolute neutrophil count <500/uL without hematopoietic growth factor support
• hemoglobin <9g/uL or transfusion dependent
• Diagnosis of DC with a triad of mucocutaneous features:
• oral leukoplakia
• nail dystrophy
• abnormal reticular skin hyperpigmentation, or
• Diagnosis of DC with one of the following:
• short telomeres (under a research study)
• mutation in telomerase holoenzyme (DKC1, TERT, TERC, NOP10, NHP2, TCAB1)
• mutation in shelterin complex (TINF2)
• mutation in telomere-capping complex (CTC1)
• Severe Aplastic Anemia (SAA) primary transplant with evidence of BM failure:
• Refractory cytopenia defined by bone marrow cellularity <50% (with < 30% residual hematopoietic cells)
• Diagnosis of SAA with refractory cytopenias having one of the following three:
• platelets <20,000/uL or transfusion dependent
• absolute neutrophil count <500/uL without hematopoietic growth factor support
• absolute reticulocyte count <20,000/uL
• Severe Aplastic Anemia (SAA) requiring a 2nd transplant
• Graft failure as defined by blood/marrow chimerism of < 5%
• Early myelodysplastic features
• With or without clonal cytogenetic abnormalities
• Adequate organ function defined as:
• cardiac: left ventricular ejection fraction ≥ 35% with no evidence of decompensated heart failure
• pulmonary: DLCO ≥30% predicted, no supplemental oxygen requirement
• renal: Glomerular filtration rate (GFR) ≥30% predicted
• Voluntary written consent
Exclusion Criteria:

• Acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• Pregnant or lactating
• Uncontrolled infection
• Prior radiation therapy (applies to SAA patients only)
• Diagnosis of Fanconi anemia based on DEB
• Diagnosis of dyskeratosis congenita with advanced MDS or acute myeloid leukemia with >30% blasts
Drug: Alemtuzumab, Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Biological: Stem Cell Transplant, Drug: Anti-thymocyte globulin
Dyskeratosis Congenita, Aplastic Anemia
Clinics and Surgery Center (CSC), severe aplastic anemia, Hematopoietic Stem Cell Transplant
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Immunosuppression reduction in failed allograft guided by cfDNA

The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.

Samy Riad
NA
This study is NOT accepting healthy volunteers
NCT04560582
STUDY00004458
Kidney Transplant Failure, Kidney Transplant Rejection, Kidney Transplant, Complications
Clinics and Surgery Center (CSC)
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Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)

STABILITY 2 is a 21-site multicenter, international, randomized clinical trial that will randomly assign 1236 individuals with an anterior cruciate ligament (ACL) deficient knee who are at high risk of re-injury to anatomic anterior cruciate ligament reconstruction (ACLR) using bone patellar tendon bone (BPTB) or quadriceps tendon (QT) autograft with or without a lateral extra-articular tenodesis (LET).

Jeffrey Macalena
All
14 Years to 25 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03935750
STUDY00010820
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Inclusion Criteria:

• Age 14-25,
• An ACL-deficient knee,
• Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs),
• At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score of ≥4) and/or genu recurvatum >10 degrees.
Exclusion Criteria:

• Previous ACLR on either knee,
• Partial ACL injury (defined as one bundle ACL tear requiring reconstruction/augmentation of the torn bundle with no surgery required for the intact bundle),
• Multiple ligament injury (two or more ligaments requiring surgery),
• Symptomatic articular cartilage defect requiring treatment other than debridement,
• >3 degrees of asymmetric varus,
• Inflammatory arthropathy,
• Inability to provide consent,
• Pregnancy at baseline.
Procedure: Anterior cruciate ligament reconstruction (ACLR), Procedure: Lateral extra-articular tenodesis (LET)
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Joint Instability, Bone, Joint & Muscle
Lateral extra-articular tenodesis, Autografting, Allografting, Bone-Patellar Tendon-Bone Grafting, Clinics and Surgery Center (CSC)
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Assistive Technology and Functional Outcomes Following Spinal Cord Injury

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

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

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

• Spinal cord disorder (e.g., ALS, MS, transverse myelitis, Guillain-Barre)
• SCI without neurologic impairment (i.e., ASIA Impairment Scale E ? normal motor and sensory function)
• Severe cognitive impairment
• Active military personnel
Community Health, Prevention & Wellness
assistive technology, quadriplegia, spinal cord injury, tetraplegia
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Robot-aided assessment of ankle and wrist joint proprioception in stroke survivors

Understand the extent of proprioceptive impairments in the upper and lower limbs in individuals with stroke by evaluating ankle and wrist joint proprioceptive acuity using the ankle and wrist robotic devices

Juergen Konczak
18 Years and over
Early Feasibility
This study is also accepting healthy volunteers
KIN-2021-30191
STUDY00013061
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Inclusion Criteria:
-Clinical diagnosis of ischemic or hemorrhagic stroke that occurred at least 12 months before data collection
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Nicotine Concentration and Flavor Effects on New Generation Electronic Cigarette Abuse Potential

This is a within-subject, multi-session behavioral study that will examine the roles of nicotine concentration and e-liquid flavors on subjective and behavioral measures of electronic cigarette abuse potential for young adult smokers.

Dorothy Hatsukami
18 Years and over
NA
This study is also accepting healthy volunteers
2019NTLS118
STUDY00006709
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Inclusion Criteria:
-21 to 34 years old -cigarette smokers -generally good health
Mental Health & Addiction
cigarettes, nicotine, smoking, tobacco, young adult
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