All Clinical Trials

The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD) Read Less

The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions (PCC) on physical functioning, health-related quality of life, and adipose tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will evaluate whether a weight loss intervention, including dietary modification and exercise, in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery. Read Less

The purpose of this study is to determine if sodium lauryl sulfate (SLS), a non-drug ingredient commonly added in drug products, affect absorption of drugs that are given together with the ingredient. Investigators want to find out if drug absorption is different in people taking the drug alone compared to people taking the drug with low and high amounts of sodium lauryl sulfate at the same time. Read Less

The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes. Read Less

Placement of a ureteral stent is a common urological intervention. For decades there was no valid measures available to assess quality of life issues in patients with ureteral stents, which has hampered the understanding of such symptoms and their true impact. In order to improve the outcomes associated with the placement of a stent, a validated tool is needed to measure its impact and the amount of undesirable effects it produces on patients requiring the placement of a stent. In 2003, the team of the Bristol Urological Institute developed a validated questionnaire called the: URETERAL STENT SYMPTOM QUESTIONNAIRE (USSQ). The questionnaire contains 38 items included in 6 sections. Despite the obvious need of a validated questionnaire, the latter remains unused by the community of peer urologists. Many of urologists consider it too long to be used in clinical practice and even for research purposes. This issue motivated the Canadian Endourology Group (CEG) to work collaboratively on the development of the CANADIAN ENDOUROLOGY GROUP STENT SYMPTOM SCORE (CEGSSS) in order to provide clinicians with a more useful and validated tool. To fulfill this objective, the CEG proceeds in three phases. Phase 1. A systematic, deliberative, and participatory approach mostly through face to face meetings, including patients, clinicians, and researchers in the field of Endourology to identify a minimum needs-based set of domains and items that are, clinically relevant to be included in the CEGSSS in order to ensure optimal uptake in the clinical setting. Phase 2. A pilot study to assess feasibility/acceptability and further refine the proposed set of items selected in phase 1 of the study. Phase 3. A multicentric prospective study to evaluate the validity, reliability and sensitivity to change of the CEGSSS. This research project is conducted by the Canadian Endourology Group (CEG), a panel of experts in the field of endourology in Canada. The CEG is a national member-based organization dedicated to enabling the profession to provide the highest possible standards of endourological care and to advance the science of endourology by collaboratively: 1. Fostering excellence in endourological practice through advocacy, education, research and practice support tools, 2. Leading evidence-based clinical practice through the development of practice standards and guidelines in endourology, 3. Providing continuous professional development for Canadian endourologists along the career-path continuum, 4. Providing leadership in public education for endourological conditions. Read Less

This is a prospective longitudinal study that will evaluate the unmet needs of older adults (65 and older) who return home (either directly or after short-term rehab) after an ICU hospitalization, evaluate the association of these unmet needs with clinically relevant outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed research will inform the development and evaluation of a subsequent intervention to improve functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce disability. Read Less

The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with anxiety. Read Less

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C HY-2-15. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy (MSA). The investigators will compare uptake in people with MSA with people with Parkinson disease (PD) and progressive supranuclear palsy (PSP) as well as healthy volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (not a clinical site), Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites. Read Less

18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis. Read Less

Through this prospective, single-arm cohort pilot study, we plan to explore the safety and effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears. Read Less

The objective of this study is to follow the treatment options offered to pregnant women diagnosed with cancer and study the impact that their treatment or delay of treatment has on their own health and that of their children. Read Less

Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies published in the late 1990's and early 2000's. Patients were selected by a strict, labor-intensive placebo-controlled, diagnostic block protocol and were treated using a conventional monopolar cannula that was positioned parallel to the medial branch, two to three lesions per medial branch nerve and both sagittal and oblique passes. Since the original CMBRFA publications, patient selection for CMBRFA is less strict, and new RFA cannulae have been developed to improve efficiency and safety while maintaining a large ablative lesion. Current clinical patient selection criteria for CMBRFA tend to be more relaxed than described in early research studies. However, subsequent research has shown that when selection criteria are too relaxed, outcomes are poorer. A recent cross-sectional study reported that when CMBRFA is done in patients selected by \>80% pain improvement after dual medial branch blocks, outcomes are similar to patients selected with a stricter selection protocol (100% pain relief) similar to the original CMBRFA studies. Although, the cross-sectional study suggests an appropriate selection criteria, it has not been used in any prospective studies. The Trident multi-tined cannula is a recent technology that produces a large ablative lesion distal to the triple-tined tip. This design allows a perpendicular/lateral approach to CMBRFA and only requires a single lesion at each medial branch. This differs from the conventional cannula, which produces it's most extensive ablative lesion along the cannula with minimal distal projection. As a result, it requires a parallel approach with multiple burn cycles at the same medial branch. The perpendicular approach with Trident and single lesion cycle at each medial branch are appealing for safety purposes and efficiency however, it's efficacy has not been directly compared to the standard conventional cannula. Problem: There are no randomized controlled trials comparing novel technologies like Trident cannula to the previously studied conventional cannula in patients selected with a more practical selection criteria. Purpose: To compared procedural characteristics, pain, and disability outcomes of CMBRFA using either a Trident or conventional cannula in patients with confirmed facet mediated pain (defined by ≥80% symptom reduction after dual medial branch block). Central Hypothesis: Trident cannula during CMBRFA will result in noninferior improvements in pain and function compared to conventional cannula but will significantly reduce procedural discomfort, time and radiation exposure. Specific Aims: 1. Determine the proportion of patients with a successful pain response (defined as ≥50% improvement in index pain) to Trident (T-CMBRFA) versus conventional (C-CMBRFA) at 3, 6, and 12 months. 2. Determine the proportion of patients with a successful functional response (defined as ≥10% reduction on neck disability index \[NDI\]) to T-CMBRFA versus C-CMBRFA at 3, 6, and 12 months. 3. Determine the proportion of patients with a successful perception of improvement (defined as a score ≥6 on the Patient Global Impression of Change \[PGIC\]) to T-CMBRFA versus C-CMBRFA at 3, 6, and 12 months. Read Less