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NCT ID: NCT04086121 Terminated - Dermatitis, Atopic Clinical Trials

A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032

Start date: September 24, 2019
Phase: Phase 2
Study type: Interventional

To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032

NCT ID: NCT04085978 Terminated - Hypoglycemia Clinical Trials

Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission

Start date: May 4, 2020
Phase:
Study type: Observational

Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.

NCT ID: NCT04084990 Terminated - Clinical trials for Obstructive Sleep Apnea

Sleep Apnea and Fetal Growth Restriction

SAFER
Start date: November 18, 2019
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be screened for OSA first by screening questionnaire and then by home sleep monitor. Of those patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and half will not (standard care).

NCT ID: NCT04084678 Terminated - Hypertension Clinical Trials

A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH

CAPACITY
Start date: January 20, 2021
Phase: Phase 3
Study type: Interventional

Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment

NCT ID: NCT04084366 Terminated - Clinical trials for Locally Advanced Solid Tumor

Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

Start date: December 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.

NCT ID: NCT04084015 Terminated - Cardiogenic Shock Clinical Trials

Early Insertion of Axillary Impella® With VA ECMO

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary arrest with severe pulmonary congestion. VA ECMO is the fastest way to stabilize a patient with cardiogenic shock and improve end-organ perfusion. However, one of the major disadvantages of peripheral VA-ECMO is that it provides no left ventricular unloading and increases left ventricular (LV) afterload secondary to the retrograde blood flow. Therefore, LV wall tension and myocardial oxygen demand may actually increase in the setting of VA ECMO. The Impella® device is a miniature rotary blood pump which can be inserted retrograde across the aortic valve. In this configuration, it withdraws blood from the LV and ejects it into the ascending aorta. It unloads the left ventricle, reducing LV wall tension and myocardial oxygen demand and increasing myocardial blood flow. The Impella® 5.0 is an FDA approved pump designed for intermediate support in patients with severe, cardiogenic shock. The axillary positioning allows for early extubation and ambulation and is more stable than groin placement. In present practice, the decision to place an Impella® pump in VA-ECMO patients is based on the perceived need for direct LV unloading or when a bridge device is required to transition off ECMO support. Patients with peripheral VA ECMO are managed with inotropic agents at the beginning and once patients develop pulmonary edema mechanical LV unloading is considered electively. The advantage of LV unloading with Impella® has been demonstrated in recent studies. We also reported that concomitant implantation of Impella® with VA ECMO for LV unloading resulted in improved survival and recovery of ventricular performance in patients with cardiogenic shock. Compared to delayed elective LV unloading, early LV unloading could lead to decreased pulmonary edema, improved oxygenation delivery to the myocardium, increased chance of LV recovery and improved survival. The objective of this prospective study is to assess whether the early direct ventricular unloading using axillary Impella® leads to higher rates of cardiac recovery, defined as survival free from mechanical circulatory support, heart transplantation or inotropic support at thirty days, compared with the conventional, elective placement of Impella® after developing significant pulmonary congestion.

NCT ID: NCT04083898 Terminated - Multiple Myeloma Clinical Trials

Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma

Start date: April 3, 2020
Phase: Phase 1
Study type: Interventional

Isatuximab targets and kills CD38-positive myeloma cells in manner similar to rituximab's mechanism of action on CD20-positive lymphoma cells. Based on the synergy between rituximab and bendamustine, as well as the established clinical efficacy of bendamustine and isatuximab as single agents for multiple myeloma, the logical next step is to combine isatuximab with bendamustine and prednisone. Due to lack of effective therapies in refractory multiple myeloma, herein the investigators propose studying this novel combination in this population, in order to address a significant unmet need. The aim of the investigators is to first determine the maximal tolerated dose of the combination in participants with relapsed/refractory myeloma and then to establish the efficacy of this novel combination.

NCT ID: NCT04083469 Terminated - Adolescent Behavior Clinical Trials

Identifying Student Opinion Leaders to Lead E-cigarette Interventions

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

This research will explore the feasibility of leveraging social network analysis to identify 6th grade opinion leaders to lead a school-based e-cigarette intervention. The project will be conducted for 6th graders in 8 schools in the Pittsburgh area.

NCT ID: NCT04083248 Terminated - Type 2 Diabetes Clinical Trials

Building Self-regulation Capacity in AA T2DM Women: Feasibility of EMI

Start date: September 20, 2019
Phase: N/A
Study type: Interventional

In African-Americans, the incidence of type 2 diabetes (T2DM) is ~14%. Adherence to crucial diabetes self-management (DSM) behaviors, such as engaging in physical activity (PA) is dangerously low among AA women living in disadvantaged neighborhoods. These women manage numerous chronic challenges (daily discrimination, poverty, and violence), which drain the internal energy needed for DSM. The ability to self-regulate (modify one's behaviors based on the requirements of a situation) has been associated with adherence to health behaviors, including diet and PA. This 6-week ecological momentary intervention (EMI) feasibility study has been developed to reduce energy needs of DSM through use of self-regulation strategies delivered in real-time, in the real-world setting. Twenty-six AA women will receive personalized diabetes education over two days. They will be given a personalized activity prescription and a Fitbit wrist activity monitor. During the following two weeks, they will get a personal continuous glucose monitor (CGM) and individualized "cue cards" for simple behaviors they can try when glucose levels are too high. The intervention is grounded in self-regulation theory, and targets core self-regulation components, including self-monitoring/assessment, mental contrasting of target values with actual values, and goal-setting/review. The aim for this application is to Determine the feasibility and acceptability of an ecological momentary intervention, consisting of continuous glucose monitoring, activity tracking, and personalized cue cards with behavioral choices (eating/activity) driven by the results of glucose levels. Impact: Real-time feedback on the effects of activity and eating behaviors will enable patients to make choices and see results immediately. Our intervention will offer low-income African-American women opportunities to enact behaviors in their momentary environment, and will encourage autonomous motivation for PA uptake, and improving blood glucose control. Findings from this study will have an important positive impact on our ability to create tailored, EMIs among low-income adults who have limited access to diabetes specialty care and education.

NCT ID: NCT04083170 Terminated - Clinical trials for Acute Myeloid Leukemia

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers

Start date: October 6, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of a cord blood transplant using dilanubicel and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. Dilanubicel consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, 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. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with dilanubicel may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.