[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Seattle Institute for Biomedical and Clinical Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":132},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100546085","functional-improvement-in-osa-and-copd-with-a-telehealth-lifestyle-and-exercise-intervention-100546085",false,"NCT06390345","Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention","FOCuSEd","Inclusion Criteria:\n\n* COPD: Defined by presence of airflow obstruction (FEV1\u002FFVC \\\u003C 0.70) on post-bronchodilator spirometry\n* ≥10 pack year history of tobacco use\n* Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)\n* BMI ≥ 25 kg\u002Fm2\n* Symptoms of dyspnea defined by MMRC score of ≥1\n\nExclusion Criteria:\n\n* Self-report of weight change \\>15 lbs. during prior 3 months\n* Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.\n* Severe illness from any cause\n* Diagnosis of bulimia or history of purging behavior\n* Active enrollment in pulmonary rehabilitation\n* Safety and\u002For adherence concerns due to severe physical or mental health issues or life expectancy \\\u003C 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.\n* Pregnant, lactating, or planning to become pregnant during the study period\n* Participation in other intervention studies.\n* Prisoner\n* Unable to complete surveys in English","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"NA","The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or \"enhanced\" usual care, stratifying by age (≥65 vs. \\\u003C 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the \"enhanced\" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.",[26,27,28],"Chronic Obstructive Pulmonary Disease","Obstructive Sleep Apnea","Overweight and Obesity","RECRUITING","2026-07-20",{"date":32,"type":33},"2026-07-22","ACTUAL",{"date":35,"type":33},"2024-07-29",{"date":37,"type":20},"2028-10-01",{"name":39,"class":40},"Seattle Institute for Biomedical and Clinical Research","OTHER",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100631957","optimizing-medications-and-lung-health-in-people-with-hiv-through-pharmacist-led-proactive-e-consults-100631957","NCT07507435","Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults","Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)","Inclusion Criteria:\n\n* PWH on ART for 6 months, receiving care at the VA, and one or more of the following:\n\n  1. Actively smoking\n  2. Prescribed ICS for \\>90 days\n  3. Prescribed a PPI for \\>90 days\n\n     Exclusion Criteria:\n* Enrolled in palliative care or hospice\n* if a non-VA provider is the main primary care or HIV provider\n* Are currently participating in a separate ongoing interventional clinical trial",{"count":50,"type":20},480,[23],"People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality. Several modifiable factors increase this risk, including active smoking, inadequate receipt of respiratory vaccinations, and inappropriate or prolonged use of inhaled corticosteroids (ICS) or proton-pump inhibitors (PPIs).\n\nOPTIMIZE Lung-HIV is a multicenter, patient-level randomized controlled hybrid Type 1 effectiveness-implementation trial evaluating whether a proactive, pharmacist-led E-consult intervention can improve evidence-based pulmonary pharmacotherapy for PWH. Pharmacists will review electronic health records, generate tailored recommendations, and pre-enter orders related to smoking cessation pharmacotherapy, vaccinations, and deprescribing of ICS or PPIs. Providers may enact or modify recommendations as clinically appropriate.\n\nThe trial will assess the proportion of recommendations enacted within 3 months (primary outcome) and at 12 months (maintenance) and will use mixed methods guided by CFIR and RE-AIM to evaluate adoption, feasibility, acceptability, and implementation barriers and facilitators.",[54,55,56,57,58],"HIV","Inhaled Corticosteroid","Proton Pump Inhibitor","Smoking Cessation","Pneumonia",[60,61,54],"Pharmacist","E-consult","NOT_YET_RECRUITING","2026-07-06",{"date":65,"type":33},"2026-07-07",{"date":67,"type":20},"2026-08",{"date":69,"type":20},"2029-09",{"name":39,"class":40},3,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100366289","phase-2-testosterone-replacement-in-male-cancer-survivors-with-fatigue-and-low-testosterone-100366289","NCT04049331","Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone","Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer","Inclusion Criteria:\n\n* Cancer survivors who have received chemotherapy and\u002For radiation therapy for their cancer and are now in remission for at least one year\n* Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias\n* Age: 18-54 years\n* Serum testosterone, measured by mass spectrometry (gold standard method), of \\\u003C348 ng\u002Fdl and\u002For free testosterone \\\u003C70 pg\u002Fml. The lower limits of the normal range for total testosterone in healthy young men (age 19-40 years), is 348 ng\u002FdL and the lower limits of free testosterone is \\\u003C70 pg\u002Fml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone \\\u003C348 ng\u002Fdl could be considered testosterone deficient. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone \\\u003C70 pg\u002FmL.\n* Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of \\\u003C40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)\n* Men with brain cancer (potential cognitive impairment)\n* Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months\n* Appetite stimulating agents e.g. megestrol acetate within the past 6 months\n* Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months\n* Baseline hematocrit \\>48%\n* PSA \\>4 ng\u002Fml in Caucasians; \\>3 ng\u002Fml in African-Americans\n* Men with 1st order relatives with a history of prostate cancer\n* Uncontrolled congestive heart failure\n* Severe untreated sleep apnea\n* Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months\n\n  o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score \\\u003C24\n* Serum creatinine \\>2.5 mg\u002FdL; ALT 3x upper limit of normal\n* Poorly controlled diabetes as defined by hemoglobin A1c \\>8.5%; Body mass index (BMI) \\>45 kg\u002Fm2\n* Untreated unipolar depression (treated depression with medications or counseling will be allowed\n* Bipolar disorder or schizophrenia","MALE","54 Years",{"count":82,"type":20},240,[84],"PHASE2","The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.",[87,88],"Hypogonadism, Male","Fatigue Syndrome, Chronic",[90,91,92],"testosterone","hypogonadism","cancer related fatigue","2026-06-17",{"date":95,"type":33},"2026-06-22",{"date":97,"type":33},"2021-03-22",{"date":99,"type":20},"2027-01-30",{"name":39,"class":40},2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":101},"100475602","a-prosthetic-foot-test-drive-strategy-for-improving-stability-in-veterans-with-leg-amputations-100475602","NCT05473065","A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations","A Prosthetic Foot Test-Drive Strategy for Improving Stability and Falls-Related Outcomes in Veterans With Leg Amputations","Inclusion Criteria:\n\n* has a unilateral (one leg) transtibial (below-knee) amputation\n* has used a prosthetic limb for walking for at least six months\n* has a comfortably fitting prosthetic socket\n* has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet\n* be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials\n\nExclusion Criteria:\n\n* contralateral limb or upper limb amputation that would interfere with completion of study activities\n* are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet)\n* unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress\n* current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness)\n* weight greater than 263lbs.\n* inadequate cognitive or language function to consent to participate\n* currently incarcerated\n* impaired decision-making ability or the use of a legally authorized representative","89 Years",{"count":111,"type":20},100,[23],"Objective\u002FHypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA.\n\nStudy Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6.",[115],"Amputation",[117,118,119,120,121,122,123],"amputation","rehabilitation","balance","stability","falls","emulator","prosthetics","2025-09-05",{"date":126,"type":33},"2025-09-08",{"date":128,"type":33},"2024-03-01",{"date":130,"type":20},"2026-07-31",{"name":39,"class":40},""]