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NCT02186847
This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.
NCT00748995
This is a research study examining health effects of the Iraq War, especially those effects involving mental health. This study is a follow-up to the Neurocognition Deployment Health Study (NDHS), also called "Prospective Assessment of Neurocognition in Future Gulf-deployed and Gulf-nondeployed Military Personnel: A Pilot Study." The specific purpose of this research study is to find out more about the longer lasting effects of war on mood and stress symptoms, thinking and reaction skills, and different aspects of day to day life, such as work and daily activities. Survey and test results from previous participation in the NDHS will be compared to the new information that will be obtained from participants as part of this study. The investigators expect that a total of about 817 military personnel and military Veterans will participate in the study. There are two parts to this study: (1) mail/internet/phone survey and (2) in-person assessment. The investigators will invite all NDHS participants who deployed to Iraq to participate in the survey component. The survey component of the study involves being interviewed by phone about mood and stress symptoms and head injuries and completing written survey questions by either mail or on the internet that address basic personal history (such as age, military status, gender, combat injury history), mood, stress symptoms, and stressful experiences. The phone interview will take about 2 to 2.5 hours to complete. The questionnaire part will take about 20 to 30 minutes to complete, and can be completed either by mailing back completed questionnaires or by internet using a private, individual log-in/password combination. The investigators will invite approximately 200 selected at random from the larger group of survey responders to take part in the in-person assessment. The in-person assessment involves taking a small subset of neuropsychological tasks. The tasks will be given on a computer or using paper and pencil. Participants will also be asked to complete questionnaires about work, daily activities, and health history, as well as basic health measures such as height, weight, blood pressure, heart rate, and waist size. Potential participants will be given the option of completing the in-person assessment at one of the two study sites (Seattle or Boston), or in a private setting in their community (e.g., a hotel small conference room). Altogether, this part of the study will take about 120 minutes to 140 minutes to complete.
NCT05370521
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
NCT06729606
This study looks at the safety and effectiveness of Aviptadil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.
NCT02158858
Phase 1 Part: Open-label, sequential dose escalation study of pelabresib (CPI-0610) in patients with previously treated Acute Leukemia, Myelodysplastic/Myeloproliferative Neoplasms, and Phase 2 Part: Open-label study of pelabresib (CPI-0610) with and without Ruxolitinib in patients with Myeloproliferative Neoplasms (Myelofibrosis and Essential Thrombocythemia). Pelabresib (CPI-0610) is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
NCT04459715
The primary objective of the study was to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
NCT06610461
Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation. This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.
NCT01193088
This project includes two projects. One is looking for new genes that cause Charcot Marie Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the symptoms a person has.
NCT02400190
This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.
NCT04365374
This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care.
NCT05496374
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2. The safety and tolerability of SPR720 in participants with NTM- PD 3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.
NCT05307328
This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.
NCT06492291
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
NCT05592938
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).
NCT05461573
This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.
NCT05612035
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.
NCT05421598
This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: * The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. * The randomized treatment duration will be up to approximately 60 weeks. * The scheduled number of visits will be 13.
NCT04810078
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
NCT05650229
The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.
NCT04838626
The purpose of this study was to evaluate the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) were used for the histopathology assessments.