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.

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

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 programs 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 interventions 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.

Researchers are evaluating the safety, feasibility, and diagnostic accuracy of a new PET tracer called 68Ga-SorB targeting Sortilin, a receptor highly expressed in several solid tumors including melanoma, liver, lung, pancreatic, breast, and ovarian cancers. This exploratory diagnostic study compares 68Ga-SorB PETCT imaging to the standard 18F-FDG PETCT, aiming to improve tumor detection and characterization by using a more tumor-specific tracer with fewer false positives. Participants will receive a single intravenous dose of 68Ga-SorB followed by whole-body PETCT imaging about 60 minutes after injection. The study compares these imaging results with clinically indicated 18F-FDG PETCT scans done within a set timeframe. No therapeutic treatments are given as part of this study. Approximately 40 to 50 adults with confirmed or suspected tumors will be enrolled for imaging and follow-up. During the study, participants are monitored for adverse events from tracer administration until about 24 hours post-imaging. Tumor uptake is measured using quantitative PET parameters such as SUVmax and tumor-to-background ratio. Follow-up includes pathology review and clinical assessments up to 3 months after imaging to evaluate lesion detection, diagnostic sensitivity, specificity, and overall accuracy. This research will provide initial clinical evidence to support further development of Sortilin-targeted imaging and potential future therapeutic applications.

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 areasglobal, physical, emotional, social, and spiritual healthand 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 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.

This research aims to explore the clinical significance and causes of generalized vulnerability in older adult men with serious diseases including various cancers and fractures. It seeks to establish how common these causes are among patients with severe non-cancerous diseases, local and advanced cancers, and how these vulnerabilities affect the time to fully palliative care, overall survival, and quality of life. The study also evaluates how well common screening tools used in non-cancer patients detect vulnerability in older adults with cancer. Participants are men diagnosed with conditions such as prostate cancer, lung cancer, brain metastasis, pelvic fracture, chronic subdural hematoma, or those undergoing high-dose chemotherapy and stem cell transplantation. The study is observational and involves tests designed to determine vulnerability. Patients are required to have recent cross-sectional imaging and study procedures within defined timeframes relative to treatment or hospitalization. No experimental treatments are administered. During the study, participants will undergo assessments to detect causes of vulnerability around the time of study procedures. Researchers will monitor survival, timing of palliative care adoption, and patient-reported quality of life. The study will collect clinical data and imaging results. Participation involves observational data collection without additional treatment, with the study continuing until December 2030.