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NCT ID: NCT05130060 Completed - Clinical trials for Stage IV Colorectal Cancer AJCC v8

A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer

Start date: January 10, 2022
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. This vaccine can activate the body's immune cells, called T cells. T cells fight infections and can also kill cancer cells. TAS-102 may help block the formation of growths that may become cancer. Giving PolyPEPI1018 and TAS-102 may kill more tumor cells in patients with metastatic colorectal cancer.

NCT ID: NCT05130047 Completed - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

This single-center, randomized, double-blind, placebo-controlled study is designed to compare effects of aldafermin, (NGM282), 1 mg, and placebo given daily by subcutaneous injection on bowel functions and hepatic synthesis and fecal excretion of bile acids in patients with diarrhea associated with bile acid malabsorption (BAM).

NCT ID: NCT05129657 Completed - Smoking Clinical Trials

CSD201001: Study to Assess Elements of Abuse Liability for Three Nicotine Pouches

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

This is a two-site, open-label, randomized, 5-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]) and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.

NCT ID: NCT05129618 Completed - Clinical trials for Constipation Chronic Idiopathic

Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

This is a randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031. Tolerability will be assessed using the change in complete spontaneous bowel movements (CSBM), PRO questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Screening Phase) to Week 8 (Day 56). The primary analysis will be conducted to assess the tolerability of MHS 1031 product and of the formulated placebo in randomized subjects with CIC diagnosed according to a modified Rome IV criteria.

NCT ID: NCT05129592 Completed - Beliefs Clinical Trials

Can Exposure to Brief Messages Correct Misperceptions?

Start date: November 22, 2021
Phase: N/A
Study type: Interventional

This study seeks to assess the efficacy of educational messages to correct misperceptions. A large proportion of the American population incorrectly believes that nicotine is the chemical responsible for causing cancer in tobacco products.1-3 This misconception may reduce the likelihood that established smokers who are unwilling or unable to quit tobacco product use completely will switch to less harmful non-combustible products. An online experiment will be used to test if corrective messages can reduce this misperception. The experiment will also test the effects of messages on beliefs about the relative harms of other tobacco products discussed in the message and accuracy of inferential beliefs. This will be accomplished by asking participants questions about two tobacco products that are not explicitly discussed in the messages. The experiment will test if the two components of "narrative coherence," a concept identified in previous reviews of misperception correction as effective,4-6 is effective at reducing misperceptions about nicotine. Component 1 provides an explanation for why the new information is correct and component 2 provides an explanation for how the false information came to be believed. This study will use a factorial design to test the efficacy of the component of coherence individually as well as together. Hypotheses and Research Questions: RQ1: Will participants exposed to different corrective message conditions differ in increased accuracy of beliefs (a) that nicotine does not cause cancer, (b) regarding the relative risk of e-cigarettes compared to cigarettes, (c) regarding the relative risk of very low nicotine cigarettes (VLNC) compared to cigarettes and (d) regarding the relative risk of nicotine replacement therapy compared to cigarettes. H1: Participants exposed to the nicotine corrective message with both components of coherence will be significantly more likely to increase accuracy of beliefs regarding the relative harms of (a) smokeless tobacco compared to cigarettes and (b) cigarillos relative to cigarettes compared to those exposed to messages with just one component or no components of coherence. H2: Participants exposed to the nicotine corrective message with both components of coherence will be significantly more likely to increase their intention to switch completely to a noncombustible product compared to those exposed to messages with just one component or no components of coherence.

NCT ID: NCT05129501 Completed - Domestic Violence Clinical Trials

The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children

Start date: October 9, 2021
Phase: N/A
Study type: Interventional

Adverse childhood experiences (ACEs) are unfortunately common and the known outcomes are concerning. However, very little is currently know about programs that may prevent ACEs among children such as witnessing IPV experienced by their caregivers. The purpose of this project is to adapt an existing evidence-based program (i.e., Strengthening Families) to prevent ACEs. A randomized control will be used to determine the initial efficacy of the program. The Strengthening Families program has demonstrated effectiveness in reducing substance use and initiation among youth and some preliminary evidence suggests that it may be effective at reducing child maltreatment as well. Further, the Strengthening Families program promotes family bonding and cohesion, which are protective factors against ACEs. The Strengthening Families program has been adapted by researchers at UNL (Devan Crawford and Les Whitbeck) for Native American Families (i.e., BII-ZIN-DA-DE-DAH [Listening to One Another]) to prevent substance abuse. Using the Strengthening Families and BII-ZIN-DA-DE-DAH programs, the investigators seek to adapt these programs to prevent ACEs among youth ages 10-14 and their caregivers. The program adaptations are being led by a Community Advisory Board as well as community practitioner partners. The community has named the program Tiwahe Wicaghwicayapi (Lakota for: to strengthen/improve families). Native children and/or children living in poverty, ages 10 to 14, will participate in the program with their families. Half of the families will go first and then the second half of the families will get the program after the last survey. The investigators will use surveys to see if and how the program is working and also interview some people who go through the program. A community Advisory Board is involved in all stages of this project and have the ultimate say about how data are shared.

NCT ID: NCT05129488 Completed - Contact Lens Wearer Clinical Trials

Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

The objective of this 2 hour study is to evaluate the clinical performance of Biotrue ONEday lenses with an alternate packaging solution (EPG03) compared to commercially available Biotrue ONEday lenses. This novel contact lens packaging solution contains known elements in the ophthalmic industry and is safe for use.

NCT ID: NCT05129475 Completed - Clinical trials for Healthy Participants

Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants

Start date: November 12, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.

NCT ID: NCT05129319 Completed - Clinical trials for Glabellar Frown Lines

Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD

Start date: December 16, 2021
Phase: Early Phase 1
Study type: Interventional

This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Jeuveau in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.

NCT ID: NCT05129293 Completed - Multiple Sclerosis Clinical Trials

Improving Prospective Memory Via Telehealth

TPMI
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial. The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.