Patient-Reported Outcomes (PROs)

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants' HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals' knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

Researchers are evaluating a new preoperative method using three-dimensional CT scans and virtual resection simulation to predict lung function after surgery in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS). This study aims to improve accuracy over traditional methods by accounting for differences in lung ventilation caused by tumors or emphysema. It is a prospective, multi-center, longitudinal cohort study involving 60 patients split evenly between those having lobectomy and segmentectomy. Participants will undergo detailed thin-slice chest CT scans and pulmonary function tests before surgery. Using Synapse 3-D software, doctors will create patient-specific 3-D lung models to simulate the planned lung tissue removal and calculate the fraction of ventilated lung to be resected. After surgery, patients will follow standard VATS procedures. The study includes long-term follow-up with pulmonary function tests at 3, 6, and 12 months and CT scans at 6 and 12 months to observe structural lung changes. During the study, participants will have preoperative assessments, surgery, and several postoperative visits for lung function tests and imaging. Researchers will measure how closely the predicted lung function matches actual results at 3 months, as well as longer-term accuracy at 6 and 12 months. They will also study how well the remaining lung compensates after surgery and the effect of any complications on recovery. The total participation spans about one year after surgery, allowing detailed evaluation of lung function and recovery.

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 imaging method produces three-dimensional movies that capture organ motion during breathing, which is important for improving radiation therapy planning for lung and liver cancer patients. The study aims to overcome challenges in current imaging methods to better target tumors that move with respiration. The study includes two main parts: technical development of ultra-quality 4D-MRI in healthy volunteers and evaluation of the technique in cancer patients. This involves creating a new MRI pulse sequence and image reconstruction process to achieve high spatial and temporal resolution with minimal motion artifacts. Researchers will compare the new 4D-MRI method to existing imaging and registration techniques in both healthy volunteers and patients with lung or liver tumors undergoing radiation therapy. Participants will undergo a single imaging session lasting up to two hours involving 4D-MRI scans. Healthy volunteers and cancer patients will be assessed to measure image quality and accuracy of motion modeling. The study will monitor how well the 4D-MRI technique captures tumor movement compared to current methods. The total participation time is limited to the imaging session, with no long-term follow-up mentioned.

Osteoarthritis (OA) of the knee is a common and increasing form of arthritis worldwide, particularly affecting older adults. This research aims to compare the effects of 99Tc-MDP, a drug previously used for rheumatoid arthritis and other bone diseases, with celecoxib, a commonly prescribed oral anti-inflammatory medication, in patients with knee OA. The study is designed to better understand how these treatments may help control symptoms and potentially slow disease progression in this population. Participants will receive either 99Tc-MDP or celecoxib. The 99Tc-MDP group will be given 15 mg of the drug intravenously in 100 ml of normal saline twice weekly for 5 weeks, then weekly for 10 weeks, every 2 weeks for another 10 weeks, and finally once a month for 6 months. The celecoxib group will take a 200 mg capsule orally once daily. The study is non-randomized and open-label, meaning both participants and researchers know which treatment is given. Throughout the study, participants will be assessed at baseline and at 6 and 12 months after treatment starts. Evaluations will include pain, stiffness, and knee joint function, as well as quality of life, disease staging, and imaging measurements using bone scans. Safety will be monitored by tracking any adverse events at 3, 6, and 12 months. The total participation time covers these follow-up periods to understand the treatments' effects over time.

Researchers are studying the quality of life in adults with hypertrophic cardiomyopathy (HCM), thoracic aortic dilatation (TAD), and radiation-induced heart disease (RIHD) who are not suitable candidates for surgery. This observational study aims to understand how these heart conditions affect patients' daily lives and well-being. The research seeks to identify risk factors linked to lower quality of life and changes over time to improve long-term management. Participants are adults diagnosed with HCM, TAD, or RIHD who are visiting the Cleveland Clinic for the first time for cardiac evaluation without prior or planned surgery. They will complete the Cardiac Quality of Life (QOL) Survey electronically at three points: baseline, 3 months, and 9 months. The survey covers five areas—global, physical, emotional, social, and spiritual health—and measures self-efficacy and resilience. During the study, participants will provide information through these surveys to help assess their health status across multiple domains. Researchers will compare results at 3 and 9 months to baseline to understand changes in quality of life and the impact of heritability and radiation-induced disease. The total participation time is about nine months, with ongoing monitoring through outpatient clinic visits and electronic questionnaires.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

Researchers are establishing a clinico-biological database for lung cancer by collecting biological samples and clinical data from patients. This observational study focuses on identifying biological, clinical, and tumor factors linked to tumor response to standard of care treatments. The study includes patients newly diagnosed with lung cancer or suspected lung tumors where antineoplastic treatment is planned. Participants provide blood samples, optional tumor tissue biopsies, and fecal samples at several points: before treatment starts, at the first tumor assessment, and at the first and second disease progressions. Genetic analysis is conducted on tumor or healthy tissue and blood to assess constitutional and somatic alterations. All treatments are given as part of standard care without experimental interventions. Throughout the study, clinical data are collected concurrently with sample collection to monitor disease progression and treatment response. The main outcome measured is the tumor response rate evaluated by CT scan after 8 weeks. Secondary outcomes include disease progression rate, progression-free survival, overall survival over one year, and treatment toxicity. Participants are followed over time with repeated assessments and sample collections to support the research objectives.

Researchers are studying whether highly focused and intense radiation can be safely delivered to tumors in the abdominal area or chest using a high-strength MRI-guided radiotherapy machine called an MR-Linac. This approach aims to improve treatment by limiting radiation exposure to surrounding organs while providing better imaging and real-time treatment adaptation compared to standard x-ray guided methods. The study is observational and intends to compare patient experiences and outcomes with those receiving standard treatments. The study involves using MRI-guided stereotactic ablative radiotherapy (SABR) for patients with small, localized tumors in the thorax or abdomen. This method offers superior imaging during treatment, real-time adjustments, and the possibility to collect additional research images without extra radiation. Participants will receive treatment following established guidelines for abdominal or central lung SABR. Researchers will assess if MRI guidance improves treatment delivery and patient outcomes compared to standard care. Participants will be monitored to see if over 85% complete their radiotherapy as planned within 30 months. The study will collect data on patient experiences, tumor and tissue changes during treatment, and follow-up information for at least one year. Safety is carefully monitored, especially regarding MRI compatibility. The total participation time varies, with follow-up assessments to evaluate treatment success and patient well-being after therapy.