Patient-Reported Outcomes (PROs)

Researchers are evaluating whether the introduction of dedicated hospital-based HIV teams can improve HIV testing rates among patients with HIV indicator conditions across ten European countries. This real-world, multicenter, stepped-wedge cluster randomized effectiveness-implementation trial spans four years and involves hospitals in the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. The study aims to address the current gap in HIV testing and improve early diagnosis by comparing testing rates before and after the implementation of HIV teams. The intervention involves creating local HIV teams led by HIV specialists, supported by nurses and data collectors. These teams focus on auditing and providing feedback to healthcare professionals to encourage HIV testing when indicated, reducing stigma, educating staff on HIV prevention and care, and improving linkage to local prevention services. The HIV teams use electronic health records to identify patients with HIV indicator conditions and integrate their activities into routine hospital care. Participants' data are collected retrospectively from routine care and prospectively at the healthcare professional level. Researchers measure changes in HIV testing rates, new HIV diagnoses, and variations across countries and specialties. They also assess the HIV diagnosis and care cascade, healthcare professionals' knowledge and stigma levels, and implementation outcomes such as resource use and cost-effectiveness. Monitoring includes feedback loops and evaluation of barriers and facilitators to implementation, aiming to improve HIV testing and care sustainability in hospitals.

All currently existing longevity measures are surrogate endpoints that have not been prospectively validated against actual mortality and aging outcomes. The 100-Year Human Aging Study is a prospective, pragmatic, observational trial that addresses this gap by enrolling participants in comprehensive clinical screening and following them longitudinally until death to determine which measurements - alone and in combination - are predictive of mortality, serious disease, and functional disability. The study prioritizes dynamic measurements: the physiological, cognitive, social, and environmental capacities that change with aging and are most likely to carry predictive signal for mortality and functional outcomes. These include cardiorespiratory fitness (cardiopulmonary exercise testing with ventilatory threshold analysis), strength (grip, explosive power, functional movement), mobility and balance, neurocognitive performance, sensory function (vision, hearing, smell, light touch), and metabolic function (oral glucose tolerance, continuous glucose monitoring), in addition to other testing. Structural and imaging assessments include body composition and bone mineral density by DEXA, echocardiography, resting and stress electrocardiography, spirometry, retinal fundus photography, and vascular ultrasound. Laboratory measures are drawn on-site and processed through a CLIA-certified reference laboratory. Complete medical, surgical, family, social, occupational, and environmental histories are obtained at each visit. Participation ranges from single-service visits - including standalone DEXA, cardiopulmonary exercise testing, and physician consultation - to the full two-visit comprehensive screening battery. All participation pathways contribute clinical data to the longitudinal mortality and aging outcomes linkage framework regardless of service level. Participants are encouraged to return for repeat testing to build longitudinal health trajectories across the lifespan. At enrollment and across longitudinal follow-up, the study platform generates individualized investigational constructs including biological age estimate, predicted death age, and predicted cause of death profile. These are explicitly investigational hypotheses, not validated clinical standards. Their predictive validity relative to actual mortality, aging outcomes, and functional disability is a central scientific question this study is designed to answer - both for individual measures and for composite multi-system models. All data are archived in their highest-dimensional raw form to preserve the ability to apply future analytical methods retroactively. Participants are followed with periodic contact and offered repeat screening throughout the lifespan. Longitudinal outcomes ascertainment includes all-cause mortality, cause-specific mortality, incident serious health events, chronic disease diagnosis, functional independence, disability status, and health behavior change.

Researchers are evaluating a 5-session cognitive behavioral program called the 1MoreStep intervention designed to help Black women living with HIV who have experienced intimate partner violence (IPV) in the past 2 years. The program aims to teach skills for accessing internal and external strengths, safety strategies, improving HIV care knowledge, reducing stigma, and enhancing communication to respond to HIV and IPV stigma. The intervention also addresses structural barriers to HIV care with support from an HIV care navigator. This pilot trial tests the acceptability, feasibility, and preliminary effectiveness of this trauma-informed program in improving IPV safety strategies and HIV care engagement. The 1MoreStep intervention includes 7 group sessions and one individual session delivered weekly by trained facilitators. Sessions cover topics like identifying strengths, using the COPE mnemonic for cognitive and behavioral skills, learning about HIV care and safety planning, practicing communication to combat stigma, and goal setting for safety and health. Participants also receive information about the myPlan app for personalized IPV safety planning. The comparison group attends 7 weekly support group sessions covering general health topics but not focused on HIV or IPV care engagement. Both groups participate in follow-up assessments at 3 and 6 months. Participants complete baseline questionnaires and attend in-person sessions at a community clinic. Researchers monitor attendance and treatment acceptance during the 7-week program and conduct surveys and interviews at 3 and 6 months to assess changes in IPV safety strategies and HIV care engagement. The study also gathers qualitative feedback on program fit and barriers to participation. This approach helps understand the intervention's impact on medication adherence, viral load, and use of safety resources over time.

Researchers are evaluating a new preoperative assessment method that uses three-dimensional (3-D) computed tomography (CT) reconstruction and virtual resection simulation to better predict lung function after surgery in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS). This study addresses the limitations of traditional methods, which often inaccurately estimate lung function by assuming equal contribution of all lung segments, ignoring differences caused by tumors or emphysema. The goal is to improve safety by providing a more precise prediction of postoperative pulmonary function using a novel measurement called the Planned Resected Ventilated Lung Volume Fraction (pRVLVF).

Researchers are developing advanced four-dimensional magnetic resonance imaging (4D-MRI) techniques to create detailed moving images of the lungs and liver in adults. This technology aims to improve radiation therapy for cancer patients by accurately capturing tumor size, shape, location, and movement caused by breathing. The study focuses on enhancing treatment planning for lung and liver cancer by using better imaging methods that can precisely track tumor motion. The study involves creating ultra-quality 4D-MRI scans with high spatial and temporal resolution and minimal motion artifacts. Healthy volunteers and cancer patients will undergo these scans, which will be compared to current imaging methods like deformable image registration (DIR) and four-dimensional computed tomography (4D-CT). The research includes two parts: developing the imaging technique in healthy subjects and evaluating its performance in cancer patients receiving radiation therapy. Participants will have a single imaging session lasting up to two hours, during which image quality and motion modeling accuracy will be assessed. The study measures the quality of images produced and compares errors in motion estimation between 4D-MRI and existing methods. Safety and compliance with imaging protocols are monitored, and findings aim to support improved, personalized radiotherapy treatments for lung and liver cancer.

Researchers are evaluating a new molecular imaging probe to improve early tumor diagnosis. This probe targets fibroblast activating protein (FAP) and is labeled with technetium-99m for SPECT/CT imaging. The study aims to address challenges with current small molecule FAP inhibitors that clear quickly from tumor tissue and have short retention times, by optimizing the ligand for better imaging and safety in clinical use. Participants will receive an intravenous injection of the 99mTc labeled FAPI imaging agent. After drinking 300-500 ml of water, they will undergo SPECT-CT imaging one hour later to visualize tumor uptake of the probe. This imaging method is designed to help detect tumors in patients with head and neck tumors, lung cancer, or pancreatic cancer. During the study, researchers will monitor tumor uptake of the probe one hour after administration. Participants must complete informed consent and meet health criteria including kidney and liver function tests before joining. The study will assess safety and effectiveness of the imaging agent in tumor diagnosis, with close monitoring of participants' physical condition and laboratory values throughout the process.

Osteoarthritis of the knee is a common and growing health concern worldwide, especially with an aging population leading to more disability and healthcare costs. Researchers are exploring new treatments to better manage knee osteoarthritis symptoms and prevent worsening of the disease. This study compares the effects of 99Tc-MDP, a drug with anti-inflammatory properties previously used for rheumatoid arthritis, to celecoxib, a commonly prescribed oral medication, in patients with knee osteoarthritis. The study involves two treatment groups: one receiving 99Tc-MDP intravenously, starting twice a week for 5 weeks, then weekly for 10 weeks, biweekly for 10 weeks, and monthly for 6 months; the other group taking a daily 200mg capsule of celecoxib by mouth. This treatment schedule aims to assess the safety and effectiveness of 99Tc-MDP compared with celecoxib over time. Participants will be monitored through assessments of knee pain, stiffness, and joint function at the start of the study and after 6 and 12 months of treatment. The study includes imaging scans to evaluate knee inflammation and collects patient-reported outcomes to understand the impact on daily activities. The overall goal is to improve knowledge about managing knee osteoarthritis and to evaluate these treatments' impact on patients' quality of life.

Researchers are evaluating the quality of life in adults aged 18 to 70 who have hypertrophic cardiomyopathy, thoracic aortic dilatation, or radiation-induced heart disease. These patients are being studied to understand how these cardiac conditions affect various aspects of life, including physical, emotional, social, and spiritual well-being. The study is prospective, longitudinal, and observational without comparison or randomization, aiming to fill gaps in knowledge about the impact of these diseases on daily living and overall health satisfaction. Participants complete the Cardiac Quality of Life Survey electronically at three time points: baseline, 3 months, and 9 months after the first visit. This survey covers five key domains: global, physical, emotional, social, and spiritual health. It also assesses self-efficacy and resilience, which relate to the patient's confidence in managing their health and their ability to cope with challenges. Patients included are those newly seen at the Cleveland Clinic for these cardiac conditions and not scheduled for surgery during the study period. Throughout the study, participants' quality of life is monitored using survey measures that capture changes over time in various health domains. Researchers compare survey results at 3 and 9 months to the baseline to assess improvements or declines in well-being. The study also evaluates the impact of hereditary cardiac disease and radiation-induced heart disease. Participant involvement includes completing online questionnaires from home, with assessments focused on physical symptoms, emotional health, social support, spiritual outlook, and overall health satisfaction, helping clinicians better manage long-term effects of these cardiac diseases.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus type 1 called R130 in patients with advanced solid tumors. This early phase 1, open, single-armed clinical trial aims to study how well this oncolytic virus injection works in treating various cancers such as sarcoma, carcinoma, digestive, breast, lung, brain, melanoma, gynecologic, head and neck, and kidney cancers. The study focuses on patients who have failed standard treatments or are unwilling to receive other antitumor therapies. Participants will receive injections of the recombinant oncolytic herpes simplex virus type 1 (R130), which is engineered to include genes coding for anti-CD3 scFv, CD86, PD1, and HSV2-US11. The treatment is given directly into tumors or the peritoneal cavity at doses and schedules defined by the study protocol. This trial consists of a single treatment arm without a comparison group. During the study, up to 20 participants will be monitored for adverse events and laboratory abnormalities over periods up to six months and one month, respectively. Researchers will assess systemic immune responses to the treatment and track safety outcomes. Participants will undergo regular evaluations including laboratory tests and clinical assessments to measure treatment effects and monitor overall health throughout the study duration.

Researchers are establishing a biological bank linked with clinical data to study lung cancer. This prospective, single-center interventional study collects blood samples, optional tumor tissue, and fecal samples from participants. These samples are gathered before treatment begins, at the first tumor assessment, and at the times of first and second disease progression. The main goal is to find biological, clinical, and tumor-related factors that relate to tumor response to standard care treatments. Participants receive treatment according to the current standard of care. Additional tissue biopsies are performed during diagnostic or therapeutic procedures to collect tumor and healthy tissue samples. Extra blood samples are also taken during standard care sampling procedures. Genetic analysis is conducted on tumor or healthy tissue or blood samples for those who consent to DNA banking. Throughout the study, clinical data are collected at each sampling time point. Researchers assess tumor response using CT scans at 8 weeks. The study monitors participants through these procedures to gather comprehensive biological and clinical information. The overall participation duration depends on individual treatment courses and disease progression assessments.