StudyFinder
Search Results
630 Study Matches
Killer Immunoglobulin-Like Receptor Interactions to Optimize Natural Killer Cell Function in SCT
Roberts, Catherine, H. - croberts2@vcu.edu
Toor, Amir, A
15122
HM20016672
Other Hematopoietic
Biomarkers of Malignant and Non-Malignant Pleural Effusion
Narron, Kyle, A - Kyle.Narron@vcuhealth.org
Shojaee, Samira
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
NCT05291559
HM20023567
Infectious and Parasitic Diseases (001-139)
HEALEY ALS Platform Trial - REGIMEN E
Smith, LaVon - lavon.smith@vcuhealth.org
Gwathmey, Kelly
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
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
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
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
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.
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
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
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
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
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
17440
HM20020118
Any Site
Assessing Electronic Cigarette Nicotine Flux (Project 2 Flux Study)
ctrrecruit@vcu.edu
Breland, Alison
19170
HM20018580
Any Site
Longitudinal Survey and Behavior Assessment of Experienced E-cigarette Users (P4 @ VCU)
ctrrecruit@vcu.edu
Breland, Alison
19168
HM20018209
Any Site
Salad Bars in the National School Lunch Program
ctrrecruit@vcu.edu
Bean, Melanie, K.
19167
HM20012226
Any Site
Predicting Effects of Tobacco Product Flavor Regs Among Black/African American Menthol Smokers
ctrrecruit@vcu.edu
Cobb, Caroline
19166
HM20022619
Any Site
Effects of E-Cigarette Nicotine Delivery on Abuse Liability in Smokers
ctrrecruit@vcu.edu
Cobb, Caroline
19165
HM20018290
Any Site
Noninvasive Assessment of Esophageal Varices in Patients with Unresectable Hepatocellular Carcinoma
ctrrecruit@vcu.edu
Wedd, Joel
19108
HM20023235
Pt QoL & Social Support after Cytoreductive Surgery & Hyperthermic Intraperitoneal Chemo
Freudenberger, Devon - devon.freudenberger@vcuhealth.org
Trevino, Jose
19045
HM20023396
Soft Tissue
Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis (RheSolve)
Brett Bannan - brett@galatherapeutics.com
Shepherd, Ray, Wes
NCT04677465
HM20022653
Inclusion Criteria:
• Patient is at least 35 years of age.
• Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
• Patient has a CAT score ≥ 10.
• Patient has an SGRQ score ≥ 25.
• Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is > 20 points.
• Patient has FEV1/FVC < 0.70.
• Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
• Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
• Patient has a cigarette smoking history of at least ten pack years.
• In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule
Exclusion Criteria:
• Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
• Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
• Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
• Patient has unresolved lung cancer.
• Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
• Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.
• Patient has emphysema of greater than or equal to 25% as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT Core Lab.
• Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
• Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
• Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
• Patient is unable to walk over 225 meters in 6 minutes.
• Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
• Patient has uncontrolled GERD.
• Patient has known severe pulmonary hypertension.
• Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
• Patient is pregnant, nursing, or planning to get pregnant during study duration.
• Patient is currently participating in another clinical study involving an investigational product
Device: RheOx Bronchial Rheoplasty, Device: Sham Procedure
Chronic Bronchitis
COPD
Role of GABA in Motor Symptoms and Neurophysiological Abnormalities in Dystonia
Crump, Elizabeth - crumpeg@vcu.edu
Berman, Brian
18815
HM20021040
Diseases of Nervous System and Sense Organs (320-389)
Cancer Prevention for Virginia Firefighters
ctrrecruit@vcu.edu
Burch, James
18656
HM20022904
Any Site
ECMT? Consortium (ECMT2)
Ghobrial, Silvia - ghobrials@vcu.edu
Randall, Leslie
18243
HM20022876
Other Female Genital, Corpus Uteri
UPBEAT-DIET (UPBEAT_Die)
Bellissimo, Moriah - Moriah.BellissimoMyers@vcuhealth.org
Hundley, W. Gregory
18021
HM20021545
Breast
Women's Treatment Experiences Study (WTES)
ctrrecruit@vcu.edu
Sheppard, Vanessa, B.
17999
HM20020923
Breast
Validation of the BLESS Models for Predicting Survival in Breast or Lung Cancer
Shojaee, Samira - samira.shojaee@vcuhealth.org
Shojaee, Samira
17961
HM20021607
Any Site