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NCT ID: NCT03725436 Active, not recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors

Start date: January 24, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of ALRN-6924 when given together with paclitaxel in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ALRN-6924 and paclitaxel, 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.

NCT ID: NCT03725332 Active, not recruiting - Clinical trials for Neonatal Abstinence Syndrome

The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky

PATH
Start date: March 13, 2019
Phase: N/A
Study type: Interventional

Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities. Investigators at the University of Kentucky/UK HealthCare (UK) have developed a comprehensive clinical care model for perinatal OUD (known as UK-PATHways) that has demonstrated success in maternal and neonatal outcomes. The overreaching goals of the proposed project are to: 1) expand the reach of this successful clinical program, 2) to reduce the impact of perinatal OUD in underserved rural areas of our state, and 3) to compare the relative effectiveness methods of delivery active elements of the PATHways program for rural implementation (local group-support vs. UK nurse/counselor telemedicine)

NCT ID: NCT03725202 Active, not recruiting - Clinical trials for Giant Cell Arteritis (GCA)

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

SELECT-GCA
Start date: January 24, 2019
Phase: Phase 3
Study type: Interventional

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.

NCT ID: NCT03725059 Active, not recruiting - Breast Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

NCT ID: NCT03725007 Active, not recruiting - Clinical trials for Juvenile Idiopathic Arthritis (JIA)

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

SELECT-YOUTH
Start date: June 24, 2019
Phase: Phase 1
Study type: Interventional

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.

NCT ID: NCT03724747 Active, not recruiting - Clinical trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer

Start date: December 18, 2018
Phase: Phase 1
Study type: Interventional

The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate cancer. In this study, this investigational medication will be administered to patients for the first time. The primary objective of the study is to define the safety and tolerability profile and Maximal Tolerated Dose (MTD) of BAY2315497 Injection alone, or in combination with darolutamide. The secondary objectives are to determine the recommended dose for further clinical development of BAY2315497 Injection alone, or in combination with darolutamide and to investigate how the study drug is distributed and cleared from the body.

NCT ID: NCT03724695 Active, not recruiting - Heart Failure Clinical Trials

Advanced Heart Care at Home

AHCAH
Start date: November 13, 2018
Phase: N/A
Study type: Interventional

End-of-life (EOL) care for heart failure (HF) patients includes high healthcare utilization and costs, in part due to the lack of integration of optimal HF management and home-based palliative care. In a pilot quality improvement project of clinician "nudges" to enroll seriously ill HF patients in a home-based, integrated HF and palliative care platform, the investigators demonstrated decreased healthcare utilization and costs and increased hospice utilization among seriously ill HF patients. The investigators propose a pragmatic randomized trial for clinicians of seriously ill HF patients admitted to three University of Pennsylvania Health System Hospitals, randomly assigning an opt-in approach (usual care) versus a "nudge" or opt-out approach of a visit from an Advanced Heart Care at Home (AHCAH) liaison to clinicians of eligible patients to discuss and enroll in the AHCAH program, to rigorously and scientifically evaluate clinical, utilization, and cost outcomes among high-risk HF patients at the EOL, and to promote physician uptake of best practices.

NCT ID: NCT03724331 Active, not recruiting - Lung Cancer Clinical Trials

Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

Start date: June 4, 2019
Phase: N/A
Study type: Interventional

Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.

NCT ID: NCT03724097 Active, not recruiting - Cancer Clinical Trials

Identification of Molecular Biomarkers for Cancer Target Therapy Efficacy

Start date: October 17, 2017
Phase:
Study type: Observational

This is a prospective trial for a computation-based efficacy prediction method for anticancer target therapies. The original computational algorithm utilizes individual transcriptome data of a cancer sample and assesses changes at the level of gene expression and intracellular signaling pathways. By applying the database of known molecular targets of anticancer target drugs it allows to rank potential efficacies of target drugs.

NCT ID: NCT03723694 Active, not recruiting - Inflammation Clinical Trials

Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

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

The purpose of this study is to test the effect of a cocoa-derived dietary flavanol on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. Th investigators will also examine the role of inflammation in this relationship.