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NCT ID: NCT03634527 Terminated - Clinical trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)

Auricular Point Acupressure: Examining the Scientific Underpinnings of Pain Relief

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Chemotherapy-induced peripheral neuropathy (CIPN)-numbness, burning and stunning pain distributed in hands and feet-is a major challenge among cancer patients. Even after completion of chemotherapy, CIPN persists among ~30-40% of cancer patients, which can negatively impact quality of life. The only drug (duloxetine) better than placebo in a randomized control trial improved pain intensity by 0.72 points on a scale of 0-10, which cannot manage CIPN effectively. A better pain management strategy clearly needs to be developed. The investigators propose to test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and effective pain relief so that cancer patients can self-manage their CIPN. APA involves an acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and index finger, three times a day (morning, noon, and evening) for three minutes each session to achieve pain relief. The investigators have developed a detailed APA protocol to teach health-care providers without experience in acupuncture and traditional Chinese Medicine that investigators can learn about APA in brief educational seminars as a treatment including the systematic identification of ear points (called auricular diagnosis). The investigators teach methods that enable patients to continue using APA to self-manage their pain. However APA is not available in current U.S. health care setting yet. Quantitative sensory testing (QST) and fMRI in acupuncture have provided new objective methods for measuring pain. QST provides an evaluation of peripheral and central mechanisms of pain by quantifying stimulus-evoked negative and positive sensory phenomena to evaluate a participant's perception of threshold values regarding pain generated through touch (A beta fibers), warmth (C fibers), cold (A delta fibers), and heat (C fibers). Studies have demonstrated changes in heat, pressure, and mechanical pain thresholds immediately following acupuncture; however no study in APA yet. Brain imaging studies in acupuncture indicate that acupuncture can restore normal functional connectivity related to pain reduction. In conjunction with the investigators pilot data demonstrating that APA impacts neural-immune signaling in patients with chronic low back pain, the investigators hypothesize that APA may likewise induce pain relief through the stimulation of A beta fibers and/or C fibers to increase the pain threshold, endogenous opioid binding (releasing inflammatory cytokines), and alter brain networks of central processing in the hypothalamic-pituitary-adrenocortical axis to achieve analgesia. The investigators plan to study the mechanisms underpinning pain sensitivity and pain processing due to APA on CIPN. Along with the clinical and subjective CIPN outcomes, objective outcomes will include physiological change in pain sensory thresholds (measured by quantitative sensory testing), brain change associated with pain processing (measured by fMRI), and neuro-transmitters (measured by inflammatory cytokines).

NCT ID: NCT03634228 Terminated - Clinical trials for Acute Myeloid Leukemia

Milademetan Tosylate and Low-Dose Cytarabine With or Without Venetoclax in Treating Participants With Recurrent or Refractory Acute Myeloid Leukemia

Start date: December 17, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of milademetan tosylate and to see how well it works with cytarabine with or without ventoclax in treating participants with acute myeloid leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Milademetan tosylate and ventoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, 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. It is not yet known if giving milademetan tosylate and low-dose cytarabine with or without ventoclax will work better in treating participants with recurrent or refractory acute myeloid leukemia.

NCT ID: NCT03634072 Terminated - Tetralogy of Fallot Clinical Trials

Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -

TOFandPVR
Start date: July 6, 2018
Phase: N/A
Study type: Interventional

Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary regurgitation (PR) which cause RV enlargement with right heart failure, diminished biventricular function, ventricular arrhythmia, sudden death and decreased exercise performance over time. Pulmonary valve replacement (PVR) has been thought to ameliorate these complications but the timing of replacement has yet to be determined with equipoise at the moment in this decision making process. As nearly all studies in this regard are retrospective with much less data in pediatric TOF than adults, this pilot trial sets the stage to create a prospective randomized trial in the teenage years.

NCT ID: NCT03633526 Terminated - Cystic Fibrosis Clinical Trials

Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

Start date: August 3, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes. The study was discontinued after completion of Part A due to Sponsor's discretion.

NCT ID: NCT03633513 Terminated - Parkinson Disease Clinical Trials

Parkinson's Disease Inflammatory Biomarker Profiling

Start date: July 10, 2018
Phase:
Study type: Observational

This study compares a comprehensive panel of immunological biomarkers between Parkinson's disease patients and healthy, environmentally matched participants. This unique study design provides the ability to control for differences in environment between study subjects. The goal of this study is to 1) identify a specific set of immunological markers that correlate with a clinical diagnosis of Parkinson's disease and 2) stratify patients by disease severity using these same biomarkers.

NCT ID: NCT03633227 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

Start date: June 22, 2018
Phase: Phase 4
Study type: Interventional

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.

NCT ID: NCT03633071 Terminated - Satisfaction Clinical Trials

Prospective Trial of the TriFitâ„¢ Web Knee Brace

Start date: February 12, 2018
Phase:
Study type: Observational

This is a prospective trial comparing improvements in pain, function, and quality of life in patients with early-stage knee osteoarthritis conservatively managed with the TriFitâ„¢ Web Knee Brace. The study design will represent a consecutive series of conservatively managed patients with knee-pain not yet candidates for surgical intervention and is non-comparative in nature.

NCT ID: NCT03632967 Terminated - Clinical trials for Heart Valve Diseases

Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Start date: September 12, 2018
Phase: N/A
Study type: Interventional

The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

NCT ID: NCT03632954 Terminated - Wounds Clinical Trials

Cytal® Wound Matrix and MicroMatrix® Wound Study

Start date: December 11, 2018
Phase:
Study type: Observational

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

NCT ID: NCT03632655 Terminated - Prostate Cancer Clinical Trials

A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches

Start date: December 23, 2017
Phase: N/A
Study type: Interventional

This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.