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631 Study Matches
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia (SCIMS Main)
Ashraf Gorgey, MPT, PhD, FACSM, FACRM - Ashraf.Gorgey@va.gov
NA
NCT05423600
Inclusion Criteria:
• A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
• Participants must have a companion that will be able to help him/her throughout the study.
• Greater than 1-year post SCI, neurologic level of C8 or above.
• American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
• Visible muscle contraction response to NMES wrist extensors, bilaterally.
• Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
• Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
Exclusion Criteria:
• Unhealed fracture in upper or lower extremities.
• Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
• High resting blood pressure greater than 140/80 mmHg.
• Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
• Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
• Implanted pacemakers and/or implanted defibrillator devices.
• Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
• Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
• Other exclusion criteria at the discretion of the medical team may include:
• Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
• Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
• Unresolved deep vein thrombosis.
• Psychiatric or cognitive impairments that preclude adherence to the intervention.
• Known cardiac pathology that precludes safe participation.
• Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
• Presence of pressure sores stage three or greater.
• Presence of a symptomatic urinary tract infection.
• Severe spasticity as assessed by the Modified Ashworth Scale.
• Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
PROCEDURE: BES + TS, PROCEDURE: Experimental: BES+sham TS
Tetraplegia/Tetraparesis
Spinal Cord Injury
Children's Bipolar Network Treatment Trial I (CBN)
David J Miklowitz, PhD - dmiklowitz@mednet.ucla.edu
NCT05427123
Inclusion Criteria:
* Youth 9-19 years old
* Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening
* Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up
* Youth has a caregiver able to participate in ongoing basis in assessment and treatment
* The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.
Exclusion Criteria:
* Youth has DSM-5 diagnosis of autism spectrum disorder
* Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos.
* Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment
* Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers
* Evidence of recent intimate partner violence between caregivers responsible for the youth's care OTHER: Medication or psychosocial treatment
Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder, Adolescent - Emotional Problem
medication, psychosocial, treatment, longitudinal, naturalistic, assessment
GiST (GiST)
Vences, Karina - venceskm@vcu.edu
Goldman, Myla
Pilot
NOT REQUIRED
HM20022775
Diseases of Nervous System and Sense Organs (320-389)
Uptake of NCI Research Tested Intervention Program to Increase CRC Screening in Rural Setting
Preston, Michael - prestonm2@vcu.edu
Preston, Michael
N/A
16928
HM20019703
Rectum, Colon
Community Outreach and Engagement Key Informant Interviews
Cummings, Yvonne - yvonne.cummings@vcuhealth.org
Sheppard, Vanessa, B.
N/A
15900
HM20018062
A Cognitive Task Analysis of Pediatric Hematology/Oncology Faculty
DiazGranados, Deborah - diazgranados@vcu.edu
Helou, Marieka, Ann
N/A
15801
HM20017417
CASTOR-2: Identifying Subclinical Cardiotoxicity Following RT for Locally Advanced Lung Cancer (CASTOR-2)
Kontos, Emily - kontosej@vcu.edu
Thomas, Georgia
N/A
15564
HM20017432
Lung
Killer Immunoglobulin-Like Receptor Interactions to Optimize Natural Killer Cell Function in SCT
Roberts, Catherine, H. - croberts2@vcu.edu
Toor, Amir, A
N/A
15122
HM20016672
Other Hematopoietic
Biomarkers of Malignant and Non-Malignant Pleural Effusion
Narron, Kyle, A - Kyle.Narron@vcuhealth.org
Shojaee, Samira
N/A
15081
HM20012669
Any Site
Acceptability and Efficacy of Enterade in Children at Risk for Environmental Enteric Dysfunction
Minter, Sabrina - sabrina.minter@vcuhealth.org
Donowitz, Jeffrey
Pilot
NCT05291559
HM20023567
Infectious and Parasitic Diseases (001-139)
HEALEY ALS Platform Trial - REGIMEN E
Smith, LaVon - lavon.smith@vcuhealth.org
Gwathmey, Kelly
II/III
NCT05136885
HM20022250E
drug: Trehalose
Diseases of Nervous System and Sense Organs (320-389)
OL Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV Generalized MG (ADAPT NXT) (ADAPT NXT)
Wilkins, Bridget - bridget.wilkins@vcuhealth.org
Gwathmey, Kelly
III
NCT04980495
HM20023221
drug: Argx-113
Diseases of Nervous System and Sense Organs (320-389)
ASCEND - Post-Market Follow-Up - Patients Treated with On-X Ascending Aortic Prosthesis
Han, Jinfeng - jinfeng.han@vcuhealth.org
Quader, Mohammed
IV
NCT05082454
HM20023997
Modality: No vcuhs billing
Diseases of Circulatory System (390-459)
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH (Symmetry)
Lester Scholtes, Rebecca - Rebecca.Lester@vcuhealth.org
Asgharpour, Amon
II
NCT05039450
HM20023488
drug: Efruxifermin
Diseases of Digestive System (520-579)
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) (MK3475-C93)
Toll Free Number - Trialsites@merck.com
Miller, Devin, T
Phase 3
NCT05173987
HM20023914
The main inclusion and exclusion criteria include but are not limited to the following:
• Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR
• Has received no prior systemic therapy for EC except for the following:
• May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
• May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP)
• Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP
• Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology
• Is Hepatitis B surface antigen (HBsAg) positive but has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization
• Has a history of Hepatitis C virus (HCV) infection but has undetectable HCV viral load at screening.
• Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed
• Has EC of any histology that is proficient mismatch repair (pMMR)
• Is a candidate for curative-intent surgery or curative-intent radiotherapy
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
• Has received prior systemic anticancer therapy including investigational agents for EC. This includes any chemotherapy given for EC other than as a radiosensitizer
• Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
• Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded
• Has known active CNS metastases and/or carcinomatous meningitis
• Has a known intolerance to any study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection, requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has had an allogenic tissue/solid organ transplant
Inclusion Criteria:
• Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR
• Has received no prior systemic therapy for EC except for the following:
• May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
• May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP)
• Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP
• Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology
• Is Hepatitis B surface antigen (HBsAg) positive but has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization
• Has a history of Hepatitis C virus (HCV) infection but has undetectable HCV viral load at screening.
Exclusion Criteria:
• Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed
• Has EC of any histology that is proficient mismatch repair (pMMR)
• Is a candidate for curative-intent surgery or curative-intent radiotherapy
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
• Has received prior systemic anticancer therapy including investigational agents for EC. This includes any chemotherapy given for EC other than as a radiosensitizer
• Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
• Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded
• Has known active CNS metastases and/or carcinomatous meningitis
• Has a known intolerance to any study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection, requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has had an allogenic tissue/solid organ transplant
Biological: pembrolizumab, Drug: carboplatin, Drug: paclitaxel, Drug: docetaxel, Drug: cisplatin
Endometrial Neoplasms
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
Kyle Herbert - ClinicalTrials@allovir.com
McCarty, John, M.
Phase 3
NCT04390113
HM20023279
Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate
in the study:
• Male or female ≥1 year of age.
• Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
• Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
• Diagnosed with HC based on the following criteria (all 3 criteria must be met):
• Clinical signs and/or symptoms of cystitis.
• Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
• Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
• At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available. Key Exclusion Criteria Participants who meet any of the following criteria will be excluded from participation in the study:
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
• Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
• Evidence of active Grade >2 acute graft versus host disease (GVHD).
• Uncontrolled or progressive bacterial or fungal infections.
• Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
• Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
• Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
• Pregnant or lactating or planning to become pregnant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
• Male or female ≥1 year of age.
• Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
• Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
• Diagnosed with HC based on the following criteria (all 3 criteria must be met):
• Clinical signs and/or symptoms of cystitis.
• Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
• Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
• At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available. Key Exclusion Criteria Participants who meet any of the following criteria will be excluded from participation in the study:
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
• Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
• Evidence of active Grade >2 acute graft versus host disease (GVHD).
• Uncontrolled or progressive bacterial or fungal infections.
• Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
• Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
• Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
• Pregnant or lactating or planning to become pregnant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105), Biological: Placebo
BK Virus Infection, Hemorrhagic Cystitis
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (STELLAR-001
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Poklepovic, Andrew, S
I
NCT03845166
HM20023654
drug: Avelumab,
drug: Atezolizumab
Colon, Breast, Prostate, Rectum, Other Male Genital, Urinary Bladder, Other Urinary, Kidney
A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma
Stevens, Sarah - sstevens23@vcu.edu
Poklepovic, Andrew, S
I/II
NCT04833582
HM20023239
drug: Zn-c3,
drug: Gemcitabine
Bones and Joints
Unpacking Multilevel Drivers of Cardiotoxicity Disparities in Breast Cancer Survivors
Sutton, Arnethea - abrahamal@vcu.edu
Sheppard, Vanessa, B.
16953
HM20019941
Breast
Cognitive Support Technology for Postsecondary Students with Traumatic Brain Injuries
Getzel, Elizabeth, E - lgetzel@vcu.edu
Getzel, Elizabeth, E
N/A
17135
HM20019040
External Causes of Injury and Poisoning (800-999)
Prognostic Gene Expression Profiling and Adjuv Therapy in Stage IIB-C & IIIA-B Cutaneous Melanoma
Gnanasigamani Manogaram, Merlin Margaret - gnanasigamam@vcu.edu
Poklepovic, Andrew, S
N/A
17390
HM20021149
Melanoma, skin
Feasibility, Acceptability, and Preliminary Effectiveness of the ICAN QUIT Tobacco Program at VCUH
Hunley, Rachel - rachel.hunley@vcuhealth.org
Hayes, Rashelle
N/A
17440
HM20020118
Any Site
Assessing Electronic Cigarette Nicotine Flux (Project 2 Flux Study)
ctrrecruit@vcu.edu
Breland, Alison
N/A
19170
HM20018580
Any Site
Longitudinal Survey and Behavior Assessment of Experienced E-cigarette Users (P4 @ VCU)
ctrrecruit@vcu.edu
Breland, Alison
N/A
19168
HM20018209
Any Site
Salad Bars in the National School Lunch Program
ctrrecruit@vcu.edu
Bean, Melanie, K.
N/A
19167
HM20012226
Any Site
Predicting Effects of Tobacco Product Flavor Regs Among Black/African American Menthol Smokers
ctrrecruit@vcu.edu
Cobb, Caroline
N/A
19166
HM20022619
Any Site
Effects of E-Cigarette Nicotine Delivery on Abuse Liability in Smokers
ctrrecruit@vcu.edu
Cobb, Caroline
N/A
19165
HM20018290
Any Site
Noninvasive Assessment of Esophageal Varices in Patients with Unresectable Hepatocellular Carcinoma
ctrrecruit@vcu.edu
Wedd, Joel
N/A
19108
HM20023235
Pt QoL & Social Support after Cytoreductive Surgery & Hyperthermic Intraperitoneal Chemo
Freudenberger, Devon - devon.freudenberger@vcuhealth.org
Trevino, Jose
19045
HM20023396
Soft Tissue