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631 Study Matches
Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis (RheSolve)
Brett Bannan - brett@galatherapeutics.com
Shepherd, Ray, Wes
N/A
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
N/A
18815
HM20021040
Diseases of Nervous System and Sense Organs (320-389)
Cancer Prevention for Virginia Firefighters
ctrrecruit@vcu.edu
Burch, James
N/A
18656
HM20022904
Any Site
ECMT? Consortium (ECMT2)
Ghobrial, Silvia - ghobrials@vcu.edu
Randall, Leslie
N/A
18243
HM20022876
Other Female Genital, Corpus Uteri
UPBEAT-DIET (UPBEAT_Die)
Bellissimo, Moriah - Moriah.BellissimoMyers@vcuhealth.org
Hundley, W. Gregory
N/A
18021
HM20021545
Breast
Women's Treatment Experiences Study (WTES)
ctrrecruit@vcu.edu
Sheppard, Vanessa, B.
N/A
17999
HM20020923
Breast
Validation of the BLESS Models for Predicting Survival in Breast or Lung Cancer
Shojaee, Samira - samira.shojaee@vcuhealth.org
Shojaee, Samira
N/A
17961
HM20021607
Any Site
Role of Circadian Factors in Inflammation and Colorectal Adenoma Risk
Shetty, Shreya - shettysa@vcu.edu
Burch, James
N/A
17947
HM20021857
Rectum, Colon
Longitudinal Cohort Registry of Cancer Survivors
Hong, Susan - susan.hong@vcuhealth.org
Hong, Susan
N/A
17880
HM20021510
Anus, Any Site, Bones and Joints, Breast, Brain and Nervous System, Other Hematopoietic, Other Female Genital, Other Endocrine System, Other Digestive Organ, Non-Hodgkin's Lymphoma, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Skin
Multiplex Analysis of Venetoclax Sensitivity in Patients Diagnosed with AML or CLL
Lantis, Kristin - kllantis@vcu.edu
Grant, Steven
N/A
17581
HM20020962
Myeloid and Monocytic Leukemia, Lymphoid Leukemia
The Impact of Sarcopenia in Patients with Cirrhosis
Evans, Marie-Claire - marieclaire.evans@vcuhealth.org
Siddiqui, Mohammad, S
N/A
18741
HM20019626
Diseases of Digestive System (520-579)
Impacts of COVID-19 on Cigarette Smoking Behaviors
ctrrecruit@vcu.edu
Breland, Alison
N/A
19171
HM20019258
Any Site
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Suna Chung, MPH - schung60@jhu.edu
Kates, Stephen, L
PHASE3
NCT04678154
HM20022236
Inclusion Criteria:
• Injury meeting at least one of the following criteria: * Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon) requiring a second procedure for final debridement and definitive coverage / closure following the index stabilization * Gustilo type IIIB ankle fractures (OTA 44) * Gustilo type IIIB calcaneus fractures (OTA 82) * Gustilo type IIIB talus fractures (OTA 81) * Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
• Ages 18 - 64 years inclusive
• Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• Patients may have a traumatic brain injury.
• Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
• Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive wound closure or coverage was not performed prior to entrance into the study.
• Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
• Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
• Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
• Patients may have a fasciotomy.
Exclusion Criteria:
• Patient in current therapy for a wound, implant or fracture site infection related to the study site.
• Patient likely to have difficulty maintaining follow-up, including: * Diagnosis of a severe psychiatric condition * Intellectually challenged without adequate family support * Resides outside of the hospital's catchment area * Planning to follow-up at another medical center * Being a prisoner * Not having a means of contact (address, cell phone, home phone, e-mail)
DRUG: Standard of care, DRUG: Vancomycin and Tobramycin
Post Operative Surgical Site Infection
Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities
Observational - Characteristics, Treatment, Outcomes -Severe Asthma in the US (CHRONICLE)
Toft, Robin - robin.toft@vcuhealth.org
Mohan, Arjun
N/A
NCT03373045
HM20022693
Modality: No vcuhs billing
Diseases of Respiratory System (460-519)
Efficacy/Safety SPR001 (Tildacerfont) Reducing Supraphysiologic Glucocorticoid Use in Adults w CAH
Memoli, Erica, H - erica.memoli@vcuhealth.org
Gupta, Anshu
II
NCT04544410
HM20019420
drug: Spr001 (tildacerfont)
Endocrine, Nutritional, Metabolic Diseases, Immunity Disorders (240-279)
Efficacy/Safety of SPR001 (Tildacerfont) in Adults with Classic Congenital Adrenal Hyperplasia
Memoli, Erica, H - erica.memoli@vcuhealth.org
Gupta, Anshu
II
NCT04457336
HM20019413
drug: Spr001 (tildacerfont)
Endocrine, Nutritional, Metabolic Diseases, Immunity Disorders (240-279)
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
Coleman, PARIS - paris.coleman@vcuhealth.org
Smallfield, George, B
N/A
NCT04293458
HM20018839
Diseases of Digestive System (520-579)
Phase Ib/II of ARRY-614 plus either nivolumab or nivolumab+ipilimumab in advanced solid tumors
Osipova, Ekaterina - osipovak@vcu.edu
Poklepovic, Andrew, S
I/II
NCT04074967
HM20021810
drug: Nivolumab,
drug: Ipilimumab,
drug: Arry-614, Modality: Immunotherapy
Melanoma, skin, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Female Genital, Other Endocrine System, Other Digestive Organ, Lung, Liver, Lip, Oral Cavity and Pharynx, Larynx, Kidney, Eye and Orbit, Ill-Defined Sites, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE)
Hurst, Caitlin - hurstc3@vcu.edu
Sanyal, Arun, J
II
NCT04173065
HM20018948
drug: Vk2809
Diseases of Digestive System (520-579)
Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult with CIDP (ADHERE)
Smith, LaVon - lavon.smith@vcuhealth.org
Gwathmey, Kelly
II
NCT04281472
HM20018410
drug: Argx-113
Diseases of Nervous System and Sense Organs (320-389)
The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Breland, Alison - abbrelan@vcu.edu
Eissenberg, Thomas, E
N/A
NCT03861078
HM20015258
Lung
Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia
Sami, Aysha, V - Aysha.Sami@vcuhealth.org
Ellenbogen, Kenneth, A
III
NCT04072835
HM20018724
drug: Etripamil
Diseases of Circulatory System (390-459)
Improving Communication and Adherence in Black Breast Cancer Survivors (SIS) (SISTERS)
Cummings, Yvonne - yvonne.cummings@vcuhealth.org
Sheppard, Vanessa, B.
N/A
NCT05334732
HM20016396
Breast
Efficacy and Safety of Benralizumab vs Mepolizumab in Treatment of EGPA (MANDARA) (MANDARA)
ctrrecruit@vcu.edu
Ward, Brant
III
NCT04157348
HM20018295
drug: Mepolizumab,
drug: Benralizumab
Diseases of Circulatory System (390-459)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
Lindemuth, Margaret (Maggie) - margaret.lindemuth@vcuhealth.org
Siddiqui, Mohammad, S
III
NCT04104321
HM20018490
drug: Aramchol
Diseases of Digestive System (520-579)
Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (COSMID)
Kelsey M Pullar, MPH - kpullar@uw.edu
Wieghard, Nicole
NA
NCT04095663
HM20016794
Inclusion Criteria:
• Adults ≥18 years
• At least one episode of diverticulitis confirmed by CT scan (or pending confirmation) and a colonoscopy (completed or scheduled) to rule out or screen for other colon pathology concordant with screening guidelines; AND A. History of recurrent uncomplicated diverticulitis without current symptoms (AUD in remission); OR B. Persistent signs, symptoms, and concerns related to diverticular disease ≥3 months after recovery from an episode of AUD (e.g., excluding irritable bowel syndrome and other conditions in coordination with gastroenterologist)
Exclusion Criteria:
• Unable or unwilling to return or be contacted for and/or complete research surveys;
• Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
• Previous operation for diverticulitis
• Current diagnosis or previous endoscopic or surgical interventions for fistula or stricture or current significant bleeding related to diverticular disease.
• Right-sided diverticulitis
• Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen")
• Actively undergoing chemotherapy or radiation for malignancy
• Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive drugs (e.g., oral corticosteroids, anti-TNF agents), or known AIDS \[i.e., recent CD4 count \<200 \] assessed by patient history);
• Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
• Taking prescription medication for irritable bowel syndrome;
• Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
• Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
• Abdominal/pelvic surgery in the past month
PROCEDURE: Partial Colectomy, OTHER: Medical Management
Diverticulitis
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine
Lessard, Margaret "Meg" - margaret.lessard@vcuhealth.org
Meloy, Linda
III
NCT03621670
HM20014721
drug: Rmenb+omv nz,
drug: Pcv13
DSC-MRI in Measuring Cerebral Blood Volume for Early Response to Bevacizumab in Recurrent GBM
Hess, Alison - ahess2@vcu.edu
Chen, Zhi-Jian
II
NCT03115333
HM20021895
Brain and Nervous System
Validating Cell-Based Assays for ABMR After Renal Transplantation (CBA ABMR)
Baldecchi, Mary - mary.baldecchi@vcuhealth.org
Gupta, Gaurav
N/A
NCT03916822
HM20019307
Diseases of Genitourinary System (580-629)
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) (ALPINE4)
Lindemuth, Margaret (Maggie) - margaret.lindemuth@vcuhealth.org
Siddiqui, Mohammad, S
II
NCT04210245
HM20019792
drug: Ngm282
Diseases of Digestive System (520-579)