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NCT ID: NCT03862157 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Start date: February 27, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and pevonedistat may work better in treating patients with acute myeloid leukemia.

NCT ID: NCT03862131 Active, not recruiting - Breast Cancer Clinical Trials

PROactive Evaluation of Function to Avoid CardioToxicity

PROACT
Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.

NCT ID: NCT03861858 Active, not recruiting - Clinical trials for Borderline Personality Disorder in Adolescence

Dialectical Behavior Therapy for Adolescents at Rutgers University

Start date: January 2, 2019
Phase: N/A
Study type: Interventional

This project expands our existing psychological services clinic (the Dialectical Behavior Therapy Clinic at Rutgers University; DBT-RU) to include an adolescent treatment arm. Adolescents aged 13-20 and at least one caregiver will be recruited to participate in a six-month treatment study. Adolescents will be eligible to participate if they meet at least 3 criteria for borderline personality disorder, with one of those criteria being either impulsive behavior or recurrent self-harm behavior. Participants will be assessed at baseline, three-months (mid-treatment), six-months (post-treatment, and three-month follow-up.

NCT ID: NCT03861702 Active, not recruiting - Clinical trials for Locally Advanced Pancreatic Carcinoma(LAPC)

Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Start date: September 2, 2020
Phase: Phase 2
Study type: Interventional

This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).

NCT ID: NCT03861273 Active, not recruiting - Hemophilia B Clinical Trials

A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

BENEGENE-2
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate [ABR] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).

NCT ID: NCT03860987 Active, not recruiting - Clinical trials for Castrate Sensitive Prostate Cancer

Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

Background: Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called positron emission tomography/computed tomography (PET/CT) to see if there is a better way to detect prostate cancer. Objective: To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer Eligibility: Men ages 18 and older with prostate cancer that has not spread to other parts of the body Design: - Participants will have a medical evaluation to determine eligibility for the study. - Participants will take three different medications daily by mouth and receive two injections during the course of the study. - Participants will have a medical evaluation monthly (for 6 months) while taking the medications. - Participants will have prostate MRI and PET/CT scans before treatment, 2 months after starting treatment and again before surgery. The radiotracer will be given by injection about 2 hours before the whole-body scan. The PET/CT scan itself is about an hour. - Participants may be asked to do a biopsy before treatment and 2 months after starting treatment. - Participants will have a full medical evaluation before surgery to remove their prostate. - Participants will have a follow-up visit 3 months after surgery and then as needed. - Participants will be contacted once a year for their PSA and testosterone levels for 5 years...

NCT ID: NCT03860961 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Start date: August 2, 2019
Phase: N/A
Study type: Interventional

This trial studies how well increasing the dose of survivorship care planning improves care and outcomes in prostate cancer survivors receiving radiation therapy and androgen deprivation therapy. There is a need for coordinated care between the cancer care team with the primary care team. This is especially important for prostate cancer survivors who need routine cancer care follow-up with their radiation oncologist and also coordinated routine follow-up with their primary care provider (PCP). This is important because androgen deprivation therapy increases a patient's risk for developing diabetes, hypercholesterolemia, and cardiovascular events. Increasing the dose of survivorship may improve care and outcomes of cancer survivors than standard practices.

NCT ID: NCT03860168 Active, not recruiting - Critical Illness Clinical Trials

PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children

PICU Up!
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Recent decreases in Pediatric Intensive Care Unit (PICU) mortality rates have been offset by increased morbidity and length of stay for vulnerable young patients. Heavy sedation, bedrest, and delirium contribute to a PICU culture of immobility. While studies in adult ICU patients demonstrate the clinical benefits of early mobilization, fewer than 25% of critically ill children mobilize early in the children's PICU stay. The investigators have demonstrated the safety and feasibility of the 'PICU Up!' Mobility Program, which integrates sleep promotion, delirium prevention, sedation optimization as a bundle to increase mobilization. However, the generalizability and broader impact on patient- and family-centered outcomes is unknown. Therefore, there is an urgent need for trials that blend both clinical effectiveness and implementation research to create a PICU culture of mobility and improve the value of PICU care. The overall objective of the proposed research is to determine the impact of a transdisciplinary and multifaceted early mobility program on clinical outcomes and ICU-acquired morbidities in critically ill children. Additionally, the investigators will identify barriers and facilitators to high-performance bundle adoption.

NCT ID: NCT03859986 Active, not recruiting - Clinical trials for Atopic Dermatitis Eczema

Study in Subjects With Moderate Atopic Dermatitis

Start date: March 8, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of ALX-101 Gel 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 56 days in adult and adolescent subjects with moderate atopic dermatitis

NCT ID: NCT03859713 Active, not recruiting - Chronic Pain Clinical Trials

Optimize Low Back Pain

OPTIMIZE
Start date: March 22, 2019
Phase: Phase 3
Study type: Interventional

The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.