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NCT ID: NCT03920345 Terminated - SIJ Arthropathy Clinical Trials

Endoscopic Electrothermic Procedure of the Sacroiliac Joint

ESIJ
Start date: June 8, 2018
Phase: N/A
Study type: Interventional

1. Determine the rate and incidence of peri-operative & post-operative adverse events (complications, infections, re-operations, re-admissions) in the endoscopic approach for the treatment of SIJ arthropathy and chronic lower back pain (CLBP). 2. Determine the Health-Related Quality of Life (HRQoL) using EQ-5D scale, VAS (Visual Analog Scale) & ODI (Oswestry Disability Index), outcomes following the endoscopic approach for the treatment of SIJ arthropathy and chronic lower back pain (CLBP) (pre- to post-operative changes).

NCT ID: NCT03920254 Terminated - Clinical trials for Ulcerative Colitis (UC)

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

Start date: July 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

NCT ID: NCT03919799 Terminated - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Start date: June 26, 2019
Phase: Phase 2
Study type: Interventional

This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Enrolment was terminated earlier than planned for business reasons unrelated to safety. A total of 36 participants were enrolled and randomized into 3 groups to either receive orally administered belumosudil (200 milligrams [mg] once daily [QD] and 200 mg twice daily [BID]) or matched placebo in 1:1:1 ratio in the double-blind (DB) period of this study. Study drug dosing was for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the participants on belumosudil continued on the same belumosudil dose whereas the participants in the placebo group were re-randomized to one of the belumosudil doses in a 1:1 ratio.

NCT ID: NCT03919214 Terminated - Hypertension Clinical Trials

Hypertension Management in Cancer Patients

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

The investigators propose to leverage new technology using the Qardio app for iPhone and Android devices to automatically upload blood pressures, using a well-validated blue tooth blood pressure monitor (QardioArm), directly into the Duke electronic health record system (EPIC). Further, the investigators propose to develop an automated EHR (electronic health record) messaging system utilizing the home blood pressures that will be sent to the participant's PCP, with copies to the participant and the primary oncologist. This is a 12-week prospective non-randomized implementation study. 40 patients who are 18-74 years old who fall under the following criteria will be screened: 10 women with Stage 1-III breast cancer who are receiving either an anthracycleine of antiHER2 therapy, 10 men with prostate cancer on ADT, 10 individuals with CLL on ibrutinib therapy, and 10 individuals who are hematopoietic stem cell transplantation (HSCT) survivors. In Phase 1 (Weeks 1-4) of the study, participants will self-monitor their blood pressure using the QardioArm wireless upper arm blood pressure monitor 3 times per week. In Phase 2 (Weeks 5-12), the investigators will implement the auto-messaging system triggered by an abnormal weekly average systolic or diastolic blood pressure. The investigators will adapt the conceptual framework of Muldoon and colleagues whereby home blood pressure monitoring is combined with office blood pressures to optimize data for the primary care provider's clinical decision making. {Participants will be asked to complete a paper survey, upon enrollment, that will include life chaos and medication adherence questions. There will also be an end-of-study feedback survey (usability and acceptability questions through REDCap) for both the participants and their primary care providers. This is an implementation study with a descriptive analysis. The data generated from the study will be used in future studies, including testing of different interventions aimed at optimizing blood pressure control among patients on active cancer therapy. This study presents no greater than minimal risk to the subjects and adverse events are not anticipated.

NCT ID: NCT03919175 Terminated - Lymphoma Clinical Trials

Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

Start date: September 1, 2019
Phase: Phase 2
Study type: Interventional

This research is being done to assess Umbralisib and Rituximab as a first line therapy for Follicular Lymphoma or Marginal Zone Lymphoma.

NCT ID: NCT03918447 Terminated - ADPKD Clinical Trials

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

FALCON
Start date: May 29, 2019
Phase: Phase 3
Study type: Interventional

This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.

NCT ID: NCT03918122 Terminated - Clinical trials for Knowledge, Attitudes, Practice

Master Preceptor Fellowship Program: A Pilot Study

Start date: January 9, 2019
Phase:
Study type: Observational

The Master Preceptor Fellowship Pilot Study is a prospective cohort study that is being conducted to measure changes in participant knowledge, teaching efficacy, leadership skills, job satisfaction and quality of life.

NCT ID: NCT03917823 Terminated - Rib Fractures Clinical Trials

Intercostal Cryoneurolysis Following Traumatic Rib Fractures

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

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this randomized, double-masked, sham-controlled study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.

NCT ID: NCT03917719 Terminated - Clinical trials for Duchenne Muscular Dystrophy

An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

GalaxyDMD
Start date: March 14, 2019
Phase: Phase 3
Study type: Interventional

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

NCT ID: NCT03916796 Terminated - Soft Tissue Sarcoma Clinical Trials

Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery

Start date: October 31, 2019
Phase: N/A
Study type: Interventional

This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (STS). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.