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NCT ID: NCT03555721 Terminated - Clinical trials for Oropharyngeal Cancer

CytID Analysis of Oral Lesions

Start date: May 30, 2018
Phase:
Study type: Observational

The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.

NCT ID: NCT03555149 Terminated - Colorectal Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

Start date: September 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

NCT ID: NCT03554759 Terminated - Thrombocytopenia Clinical Trials

Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

Start date: July 2, 2018
Phase:
Study type: Observational

Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.

NCT ID: NCT03553732 Terminated - Prostatic Neoplasms Clinical Trials

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital

Start date: July 1, 2018
Phase:
Study type: Observational [Patient Registry]

To implement and evaluate a health information technology platform designed to support the management of patients on active surveillance for prostate cancer in an urban, publicly-funded outpatient setting.

NCT ID: NCT03553576 Terminated - Pain Clinical Trials

Drug Concentration and Volume on Adequate Labor Analgesia With PIEB

CADD2
Start date: January 9, 2020
Phase: Phase 4
Study type: Interventional

Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]) via epidural catheter. Pain during the first stage of labor is primarily due to lower uterine segment and cervical stretching. The pain signals enter the spinal cord through sensory nerves at the T10 through L1 dermatomes. Pain signals from the late first state and second stage of labor also arise from the vagina and perineum. These signals travel with the pudendal nerve and enter the spinal cord at S2-S4. Thus, the anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space. The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that PIEB, in combination with PCEA, provide superior maintenance of labor analgesia (less need and longer time to provider intervention, lower local anesthetic consumption, less motor block, and improved patient satisfaction scores) than maintenance with a continuous infusion with PCEA.The mechanism for this difference is not known; however, one suggested mechanism is improved spread of the local anesthetic within the epidural space. Kaynar et al. injected methylene blue dye through a multi-orifice catheter using either a continuous infusion or intermittent bolus and the area of diffusion was measured on a piece of paper. The authors found that intermittent boluses were associated with a greater surface area of diffusion than continuous infusion. In a cadaver study, dye was injected into the lumbar epidural space, and cryomicrotome sections were taken.Dye flowed in rivulets through small channels in the epidural space, as opposed to moving as a unified front. The authors found dye injected at high pressures had more uniform spread through the epidural space, supporting the concept of intermittent epidural injection providing superior analgesia. Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia. Recently we completed a double-blinded randomized control trial evaluating two bolus delivery rates, hypothesizing that those patients randomized to receive higher bolus delivery rates would have improved labor analgesia. However, no difference was found between groups.What is more, both groups had a mean cephalad sensory level to cold of T6. This sensory level is higher than the traditional goal of T10 (upper dermatome level of uterine innervation), but despite the adequate sensory level, a large number of patients required supplemental physician-delivered boluses of local anesthetic during labor. Forty percent of the women in the high-rate group and 36% of the low-rate group required a manual re-dose during labor. This suggests that either a higher volume, or higher concentration of local anesthetic (i.e., higher dose) is needed to maintain adequate labor analgesia. Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia. The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

NCT ID: NCT03553550 Terminated - Clinical trials for Non Small Cell Lung Cancer

Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation

LIBERTI
Start date: June 1, 2018
Phase:
Study type: Observational

The purpose of this research study is to learn more about changes in cell-free tumor DNA in blood samples, also known as a liquid biopsy, as they relate to treatment and response to treatment.

NCT ID: NCT03552120 Terminated - Pregnancy Related Clinical Trials

Serving Women Using Opioids During Pregnancy

SWOOP
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid misuse and parenting behavior among pregnant women using opioids. Specific aims are: AIM 1: To evaluate the preliminary efficacy of MORE, relative to a supportive counseling control condition, on primary outcomes (opioid misuse) and secondary outcomes (opioid craving, psychological distress) among pregnant women using opioids. Hypothesis: Participants who participate in MORE will demonstrate significantly greater improvements than the supportive visit control group on: opioid misuse behaviors, opioid craving, and psychological distress. AIM 2: To test and quantify the degree to which the impact of MORE on opioid misuse is mediated by changes in cognitive, affective, and autonomic mechanisms relevant to this clinical population - including opioid attentional bias, negative emotion regulation, reward responsiveness, and physiological reactivity to infant cues. Hypothesis: The impact of MORE on craving and opioid misuse behaviors will be mediated by improvements in attentional bias toward opioid cues, negative emotion regulation and natural reward responsiveness on the emotion regulation task, and autonomic reactivity to infant cues. AIM 3: To evaluate the impact of MORE on mothers' perceptions of their ability to parent effectively and the quality of the mother-baby relationship. Hypothesis: Participants participating in MORE will report more positive beliefs about their ability to effectively parent. Participants who participated in MORE will interact more sensitively with their newborn. Exploratory AIM 1: To evaluate the efficacy of MORE, relative to a support group control condition, on co-regulation, as measured by an index of sympathetic nervous system functioning, among pregnant women using opioids. Hypothesis 1: Dyads in which the mother participated in MORE will demonstrate significantly greater dyadic synching of sympathetic activity as measured by respiratory sinus arrhythmia (RSA). Exploratory AIM 2: To test and quantify the degree to which the impact of MORE on dyadic synchrony (during the Still Face Paradigm) is mediated by changes in negative emotion regulation and reward responsiveness. Hypothesis 2: The impact of MORE on dyadic synchrony will be mediated by improvements in negative emotion regulation and natural reward responsiveness as measured by an emotion regulation task.

NCT ID: NCT03552029 Terminated - Clinical trials for Acute Myeloid Leukemia

Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

Start date: December 12, 2018
Phase: Phase 1
Study type: Interventional

Participants with AML that have gone into remission and come back (relapsed) or gone into remission with a number of leukemia cells still in their system (refractory) will be recruited for this study. They will also be positive for FLT3-ITD mutation. Participants will receive a combined dose of quizartinib and milademetan that have not been approved by the US Food and Drug Administration yet (m). The combination of these drugs will be provided in different amounts on defined days (dosing schedules). It is expected that the combination of milademetan and quizartinib will be safe and well tolerated. It is expected that the combination may fight the leukemia better than a single drug. The study will run for approximately 3 years. There may be up to 156 participants. The study has 2 parts: - Part 1 will test 24-36 participants in approximately 15 study centers globally. Participants will receive two study drugs (milademetan and quizartinib) in different amounts on specific days. Information will be gathered to see what dosing schedule of the drug combination is best (maximum tolerated/recommended dose). - Part 2 of the study will confirm the recommended dosing schedule identified in Part 1 is effective. A larger number of participants will receive the recommended dose in approximately 15 additional sites worldwide as necessary, based on the enrollment rate, the population, and the standard of care available to them at the time of enrollment.

NCT ID: NCT03551522 Terminated - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed due to the early termination of the study

NCT ID: NCT03551418 Terminated - Down Syndrome Clinical Trials

Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome

Start date: June 9, 2018
Phase: N/A
Study type: Interventional

The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied.