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NCT ID: NCT03366844 Active, not recruiting - Breast Cancer Clinical Trials

Breast Cancer Study of Preoperative Pembrolizumab + Radiation

Start date: December 22, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy. Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.

NCT ID: NCT03366805 Active, not recruiting - Orthopedic Surgery Clinical Trials

A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.

NCT ID: NCT03365882 Active, not recruiting - Clinical trials for Rectal Adenocarcinoma

S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

Start date: November 27, 2017
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, 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. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.

NCT ID: NCT03365362 Active, not recruiting - Clinical trials for Tobacco Use Disorder

A Trial of Directly Observed and Long-term Varenicline

Start date: October 25, 2018
Phase: Phase 4
Study type: Interventional

This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic strategy will evaluate the milestones in smoking cessation-achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes.

NCT ID: NCT03364400 Active, not recruiting - Solid Tumor Clinical Trials

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

Start date: November 28, 2017
Phase: Phase 1
Study type: Interventional

This study is an an open-label Phase I trial of VT1021 in patients with advanced solid tumors. Patients must have recurrent or advanced cancer (i.e., solid tumors) for which standard therapy offers no curative potential.

NCT ID: NCT03364153 Active, not recruiting - Clinical trials for Stargardt's Macular Dystrophy

Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

Start date: January 12, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

NCT ID: NCT03363711 Active, not recruiting - Clinical trials for Adolescent and Young Adult (AYA) Cancer Survivors

AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors

Start date: March 1, 2017
Phase:
Study type: Observational

The proposed project will leverage two programs of research at UPenn and CHOP that are delivering technology-based interventions to adolescent and young adult (AYA) cancer survivors. In the proposed study, all AYA survivors will receive a care plan via a tool (Smart-ALACC). They will then be randomized to receive (or not) a mobile health application (AYA STEPS) that will provide tailored messages to enhance uptake of their care plan.

NCT ID: NCT03363464 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Comparative Effectiveness of Empagliflozin in the US

Start date: October 16, 2017
Phase:
Study type: Observational

Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.

NCT ID: NCT03363243 Active, not recruiting - Chronic Pain Clinical Trials

Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain

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

The public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the Centers for Disease Control (CDC). This study finalizes and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time in a format that could be easily used in a community addiction treatment setting. Final products of the study will yield an integrated STOP (Self-regulation/Cognitive-behavioral therapy (CBT) Therapy for Opioid addiction and Pain) manual guided protocol, patient workbook, and therapist training protocol.

NCT ID: NCT03362502 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy

Start date: January 23, 2018
Phase: Phase 1
Study type: Interventional

This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with Duchenne muscular dystrophy (DMD). Other objectives include measurement of dystrophin expression and distribution, and assessments of muscle strength, quality, and function. A total of approximately 22 subjects will receive PF-06939926, and these will include both ambulatory and non-ambulatory subjects. Up to 13 subjects may be included in a cohort that includes the concomitant medication, sirolimus. In order to mitigate unanticipated risks to subject safety, enrollment will be staggered within and between two planned dose-levels and will include a formal review by an external data monitoring committee (E-DMC) prior to dose progression.