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NCT ID: NCT05414305 Active, not recruiting - Clinical trials for Microbial Colonization

The Female Microbiome in Patients Undergoing Bladder Instillation Therapy

Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

The underlying pathophysiology for BPS/IC is currently an active area of research. There is speculation that there may be alteration in the bladder and vaginal microbiome that contributes to the symptomatology of BPS/IC, however existing literature is limited and contradictory. Nickel et al (2015) studied the bladder microbiota in women with IC/BPS during a flare versus nonflare. The study collected initial stream and midstream urine specimens and detected overall, there was no significant differences in the species composition. However, a greater prevalence of fungi (Candida and Saccharomyces) was seen in the flare group (15.7%) versus the non-flare group (3.9%) midstream urine specimens. Pearce et al (2015) sought to characterize the urinary microbiome via catheterized specimens from women with urgency urinary incontinence, a condition that can present similarly as IC/BPS. The study found that more than half of the patients were sequence positive, most commonly for Lactobacillus (45%) or Gardnerella (17%), with 25% made up of various other bacteria. In contrast, Abernethy et al (2017) showed via catheterized urine specimens from patients with IC/BPS that the urinary microbiome is less diverse and less likely to contain Lactobacillus species. There have been two recent studies investigating the female urinary microbiome in patients with IC/BPS. Nickel et al (2019) found no differences in species composition between urine from patients with IC/BPS versus controls. Meriwether et al (2019) reported similar findings, and additionally found no differences when comparing the vaginal bacterial microbiome in patients with IC/BPS versus controls. However, in evaluating the bladder microbiome, both studies utilized uncatheterized urine specimens. Wolfe et al (2012) showed microbiome differences between clean-catch and catheterized urine specimens, therefore vaginal contamination in both studies cannot be ruled out.

NCT ID: NCT05413265 Active, not recruiting - Smoking Cessation Clinical Trials

Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Aniqsaaq
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The objective of the proposed study is to evaluate the effectiveness and implementation of a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation.

NCT ID: NCT05413252 Active, not recruiting - Hypertension Clinical Trials

Team-based Care to Improve Hypertension

Start date: January 31, 2023
Phase: N/A
Study type: Interventional

The study is a stepped-wedge cluster randomized control trial to compare the effect of Practice Facilitation in 90 small-to-medium sized independent primary care practices on the adoption of team-based care.

NCT ID: NCT05413239 Active, not recruiting - Type 1 Diabetes Clinical Trials

Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)

Start date: July 26, 2022
Phase: N/A
Study type: Interventional

In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.

NCT ID: NCT05413135 Active, not recruiting - Dyslipidemias Clinical Trials

Study of ARO-APOC3 in Adults With Dyslipidemia

Start date: July 7, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.

NCT ID: NCT05413044 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register

Start date: July 1, 2019
Phase:
Study type: Observational

The purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) enrolled in the SRQ Register in Sweden.

NCT ID: NCT05412979 Active, not recruiting - Hypothyroidism Clinical Trials

A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

Start date: April 29, 2022
Phase: Phase 2
Study type: Interventional

ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary hypothyroidism.

NCT ID: NCT05412277 Active, not recruiting - Low Back Pain Clinical Trials

VIA Disc Nucleus Pulposus Older Patients Pilot

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

NCT ID: NCT05412212 Active, not recruiting - Latent Tuberculosis Clinical Trials

Brief Educational Video for Patients Prescribed LTBI Treatment

Start date: June 3, 2022
Phase: N/A
Study type: Interventional

Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate TB. The investigators hypothesize that a 3-minute educational LTBI video intervention will improve treatment completion compared to standard care (no intervention). A randomized trial will be conducted at Kaiser Permanente Southern California, including adults who are prescribed treatment for LTBI, identified using an electronic health record algorithm. At the time of treatment prescription, patients will be randomized to receive the LTBI video intervention or standard care at a ratio of 2 to 1. Those in the intervention group will be sent a secure text message or e-mail with a link to the video. Individuals who watch the LTBI video will be invited to respond to 4 short questions about their perceptions of the video accessibility and content. The primary outcome is LTBI treatment completion (dispensation of the required number of doses) in the year following prescription order. Secondary outcomes are LTBI treatment initiation (at least one dispensation) in the year following prescription order; initiation and completion within the year following prescription order stratified by LTBI treatment regimen (if feasible); the proportion of individuals randomized to the intervention group who watched the LTBI video; and the perceptions of those who watched the video. The primary analysis will be based on intention-to-treat. Characteristics of individuals in the intervention and standard care groups will be described, and rates of LTBI treatment completion will be calculated. To assess the effect of the intervention, Poisson regression with robust standard errors will be used to estimate unadjusted and adjusted rate ratios and 95% confidence intervals. Per-protocol analyses will also be conducted, comparing those in the intervention group who watched the LTBI video to those in the standard care group. Similar methods will be used for secondary analyses. Assuming the completion rate in the standard care group is 0.5 (based on recent KPSC data), approximately 918 patients will be needed to achieve 80% power with type one error 0.05 to detect an intervention effect of 0.10 in the completion rate between groups. This sample size will be feasible to achieve over the 1 year trial duration.

NCT ID: NCT05411822 Active, not recruiting - Alzheimer Disease Clinical Trials

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.