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NCT ID: NCT03258008 Not yet recruiting - Clinical trials for Oropharyngeal Cancer

Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer

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

The goal of this clinical research study is to learn if utomilumab, when given alone or combined with ISA101b, is able to shrink or slow the growth of tumors in patients with incurable HPV+ oropharyngeal squamous cell carcinoma.

NCT ID: NCT03257995 Not yet recruiting - Asthma Clinical Trials

Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

Start date: August 22, 2017
Phase: Phase 2
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.

NCT ID: NCT03257943 Completed - Lice; Head Lice Clinical Trials

A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%

Start date: March 20, 2017
Phase: Phase 1
Study type: Interventional

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

NCT ID: NCT03257917 Recruiting - Clinical trials for Metastatic Breast Cancer

Understanding Value in Metastatic Breast Cancer

Start date: June 13, 2017
Phase: N/A
Study type: Observational

The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care

NCT ID: NCT03257839 Enrolling by invitation - Breast Neoplasms Clinical Trials

Delphinus SoftVue Prospective Case Collection - ARM 1

SV PCC ARM1
Start date: July 31, 2017
Phase: N/A
Study type: Observational

The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring‐array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B‐mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non‐ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring‐shaped transducer, 22 cm in diameter, encircles the breast and pulses low‐frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi‐arm, clinical case collection program is IRB‐approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI‐RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data. The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT‐2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.

NCT ID: NCT03257761 Not yet recruiting - Clinical trials for Metastatic Pancreatic Adenocarcinoma

Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer

Start date: September 25, 2017
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of guadecitabine and how well it works when given together with durvalumab in treating patients with liver, pancreatic, bile duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as durvalumab, may block tumor growth in different ways by targeting certain cells. Giving guadecitabine and durvalumab may work better in treating patients with liver, pancreatic, bile duct, or gallbladder cancer.

NCT ID: NCT03257722 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

Pembrolizumab + Idelalisib for Lung Cancer Study

PIL
Start date: August 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1b/2 study to determine the safety and effectiveness of the combination of pembrolizumab and idelalisib in NSCLC patients whose disease has stopped responding to immune therapy. This study is being done to see if adding another immune modulator (idelalisib) to standard pembrolizumab will increase response rates, compared to the response seen with pembrolizumab alone.

NCT ID: NCT03257683 Enrolling by invitation - Clinical trials for Severe Coronary Artery Disease

RANOLAZINE STUDY: Speckle Tracking Derived Myocardial Strain

Start date: April 14, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle.

NCT ID: NCT03257670 Not yet recruiting - Dyspareunia Clinical Trials

Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors

BCLS
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse in women who are breast cancer survivors. This study will also be looking at whether or not the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function before and after treatment.

NCT ID: NCT03257657 Recruiting - Obesity Clinical Trials

Helping Moms to be Healthy After Baby

Start date: July 31, 2017
Phase: N/A
Study type: Interventional

Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below: Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women. Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.