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NCT ID: NCT03299088 Active, not recruiting - Clinical trials for Stage IV Non-Small Cell Lung Cancer AJCC v7

Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations

Start date: June 26, 2018
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects of pembrolizumab and trametinib in treating patients with non-small cell lung cancer and KRAS gene mutations that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and trametinib may work better in treating patients with non-small cell lung cancer.

NCT ID: NCT03299049 Active, not recruiting - HIV Infections Clinical Trials

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

ATLAS-2M
Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.

NCT ID: NCT03298945 Active, not recruiting - Colorectal Cancer Clinical Trials

Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens

Start date: December 13, 2018
Phase: Phase 4
Study type: Interventional

From the patients' perspective, the most formidable part of the colonoscopy experience is the process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to incompletion of scheduled colonoscopies which in turn undermines the effectiveness of colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel preparation in the VA is of larger volume and less palatable than another commonly used bowel preparation regimen. The investigators propose to compare these two commonly used bowel preparations with respect to the overall completion rate of scheduled colonoscopies in a real-world VA practice setting. The results of the study can be immediately applied to maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.

NCT ID: NCT03298477 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

EVAS2
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

NCT ID: NCT03298451 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

HIMALAYA
Start date: October 11, 2017
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

NCT ID: NCT03298373 Active, not recruiting - Healthy Men Clinical Trials

28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

CCN014A
Start date: November 9, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I multicenter, double-blind, repeat dose, dose-escalating study, in healthy men to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC).

NCT ID: NCT03297905 Active, not recruiting - Chronic Pain Clinical Trials

Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

Start date: June 15, 2018
Phase: N/A
Study type: Interventional

This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.

NCT ID: NCT03297684 Active, not recruiting - Clinical trials for Diabetic Macular Edema

Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection

Start date: April 11, 2018
Phase:
Study type: Observational

To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.

NCT ID: NCT03297060 Active, not recruiting - Alcohol Drinking Clinical Trials

Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers

IAMSBIRT
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The goal of this study is to conduct a fully powered Type III hybrid effectiveness-implementation trial to test the effectiveness of a comprehensive implementation strategy in increasing the implementation of SBIRT for alcohol and other drug use in pediatric trauma centers. Our implementation strategy is based on the Science to Service Laboratory (SSL), an approach developed by the SAMHSA-funded Addiction Technology Transfer Centers (ATTCs) that consists of the same three core elements (i.e., didactic training + performance feedback + leadership coaching) used in our Centers for Disease Control and Prevention (CDC) study. Based on feedback from the CDC study, two enhancements were made to the SSL strategy: 1) integration of the intervention into the electronic medical record as a means of improving SBIRT adherence; and 2) development of separate training tracks for nurses, social workers and organizational leaders to meet the unique needs of each group. In addition, we integrate counseling around the use of prescription pain relievers into the SBIRT intervention as an Exploratory Aim, since most pediatric trauma center patients are discharged on pain medication and patients with a history of AOD use are at elevated risk of opioid misuse. Utilizing a stepped wedge design, a national cohort of 10 pediatric trauma centers will receive the SSL implementation strategy. Data collection for this study relies on multiple sources. At six distinct time points, each of the 10 sites will provide retrospective data from EMR charts. A subset of adolescents will also report on fidelity of intervention delivery and linkage to care (i.e., continued AOD discussion and/or treatment with a primary care provider) 1 month post hospital discharge. In addition, nurses, social workers, and leaders from each pediatric trauma center will report on organizational readiness for implementation at three distinct time points. Results of this study will demonstrate that a highly scalable implementation strategy, adapted for pediatric trauma centers from the results of our mixed-methods implementation trial, will improve the fidelity (i.e., the consistency and quality) of SBIRT delivery in pediatric trauma centers.

NCT ID: NCT03296592 Active, not recruiting - Clinical trials for Cervical Spondylotic Myelopathy

Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)

CSM
Start date: January 29, 2018
Phase:
Study type: Observational

Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will have this MRI preoperatively and at 24 months postop. The investigators believe that with this imaging, biomarkers will be able to be seen to assist in prediction of long term outcomes in patients with spinal cord compression. These patients will be compared to healthy cohorts who will also undergo an MRI using the DBSI technology.