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NCT02610140
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM). 210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine. Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required. Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
NCT01633697
The investigators hypothesize that education will improve exercise capacity, symptoms and quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition, the investigators are interested in determining how education might alter various chemicals in the blood and exhaled breath that reflect inflammation in the lungs and the body as a whole. The investigators plan to enroll 42 patients into this study, with half of them participating at each of the two sites, Vermont Lung Center at the University of Vermont in Burlington, Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will undergo a series of measurements and tests at the beginning of the study, receive formal education about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session, and finally return after 12 weeks for repeat measurement and testing as was done at the beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise during the study.
NCT02605083
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eFT508.
NCT02757391
This phase I pilot trial studies the side effects of cluster of differentiation 8 (CD8)+ T cells in treating patients with gastrointestinal tumors that have spread to other places in the body. Tumor cells and blood are used to help create an adoptive T cell therapy, such as CD8+ T cell therapy, that is individually designed for a patient and may help doctors learn more about genetic changes in the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CD8+ T cell therapy and pembrolizumab may work better in treating patients with gastrointestinal tumors.
NCT02420691
This phase II trial studies how well ribociclib works in treating patients with neuroendocrine tumors of the foregut, which includes the thymus, lung, stomach, and pancreas, that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced tumors). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT00790582
This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.
NCT03304106
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
NCT00453661
The goal of this behavioral research study is to improve the use of cancer prevention services, increase early detection, and treatment of cancer. A secondary outcome of this demonstration project proposes that a structured patient navigator (PN) will reduce the cost of Medicare services.
NCT02538406
Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.
NCT01491737
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.
NCT03691831
Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts
NCT02961894
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.
NCT02267356
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines. This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months. The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.
NCT03818555
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
NCT02937675
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of Tomivosertib (eFT-508). The study will evaluate oral daily administration of Tomivosertib (eFT-508). Treatment and study subject evaluation will be performed in 21-day cycles.
NCT02134353
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population
NCT03034967
Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD. Following baseline assessments collected over a 7 day period participants will be randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram \[mg\], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for 24 weeks. Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. Follow up will continue up to 28 days post last dose. Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments.
NCT03800238
The purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivered via telehealth and one delivered in person as measured by a general rating of health, the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes delivered via telehealth and in person? This research involves a specific education-based caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost. This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by 7 pairs of class leaders. Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer. Participants will undergo assessment one week before and one week after the PTC program, and at six-month follow up. Outcome measures replicate previous PTC research and add additional outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive statistics and a mixed design analysis of variance including repeated measures to examine differences in the variables of interest over time.
NCT02760615
The purpose of this study is to evaluate in a step-wise approach the disease drug-drug interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome P-450 (CYP) substrate drugs by modulating pro-inflammatory cytokines in participants with ulcerative colitis (UC) or Crohn's disease (CD) who are treated with vedolizumab.
NCT00723957
The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.