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  • To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

    Phase

    2

    Span

    55 weeks

    Sponsor

    E-Star BioTech, LLC

    Houston, Texas

    Recruiting

  • Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors

    Phase

    1

    Span

    166 weeks

    Sponsor

    Qualigen Theraputics, Inc.

    Houston, Texas

    Recruiting

  • Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

    Phase

    3

    Span

    201 weeks

    Sponsor

    Anthos Therapeutics, Inc.

    Houston, Texas

    Recruiting

  • Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction

    Phase

    2

    Span

    167 weeks

    Sponsor

    Akros Pharma Inc.

    Houston, Texas

    Recruiting

  • Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.

    Phase

    3

    Span

    141 weeks

    Sponsor

    TransThera Sciences (Nanjing), Inc.

    Houston, Texas

    Recruiting

  • CHOICES-TEEN Randomized Controlled Trial

    This CHOICES-TEEN intervention study will use a Phase II Behavioral Treatment Trial to employ a single blind randomized design with an attention control (AC) group to assess the efficacy of the CHOICES-TEEN intervention. Young women, 14-19 years of age, entering the Harris County Juvenile Probation (HCJP) system's probation and field diversion and community probation program will be eligible for screening into the study. The investigators anticipate recruiting N=435 with 92% retention based on prior experience, yielding a total sample size of N=400, stratified by program, with 200 randomized to the CHOICES-TEEN intervention (plus Standard Care; CT) or the Attention only group (AC) using urn randomization. Both groups will be assessed at 3-, 6- and 9-month follow up. Eligibility will be determined based on the following inclusion/exclusion information. This efficacy trial will: (1) Test the efficacy of CHOICES-TEEN (CT) compared with attentional control (AC) on reducing the risk of substance-exposed pregnancy (SEP) and HIV/STI among high-risk female youth involved with the juvenile justice system by reducing alcohol use, increasing marijuana cessation, reducing pregnancy risk, and increasing condom use; (2) Test the efficacy of CT, compared to an attentional control condition, in increasing cognitive self-regulation abilities; (3) Test proposed intervention mediators/mechanisms of action for CT overall and by race/ethnicity; and (4) Test the moderating effect of initial readiness to change on risk of SEP and risk of HIV/STI. Female adolescents between the ages of 14-19 will be recruited for eligibility screening from the aforementioned community probation program. Voluntarily referred youth will be screened for eligibility in the study after obtaining parental permission and youth assent. All youth enrolled in the study must be identified as being at risk for substance-exposed pregnancy and HIV/STI. Eligible youth who provide written informed consent (and parents who provide written permission) will then be randomized to the CHOICES-TEEN intervention or the Attentional Control Condition. The investigators anticipate recruiting N=435 with 92% retention based on prior experience with similar studies, yielding a final sample size for analyses of N=400. Randomization, stratified by program, will result in n=200 participants per condition with participants clustered within k=4 forensic programs. Investigators assume a conservative ICC =0.20 due to clustering. Absolute risk reductions in risk of SEP range from 14.8% to 25.1% based on Project CHOICES, Project CHOICES Plus and our pilot CHOICES-TEEN. For the purposes of sample size justification, investigators will assume N=435 randomized in 1:1 fashion (minimum 400 completers), stratified by program, and ICC = 0.20 and a conservative estimate of an ARR=15% for reduced risk of SEP and HIV/STI. Finally, investigators stipulate that if the posterior probability that there is an effect of treatment (Odd Ratio>1.0) is greater than 0.75 and that the median treatment effect estimate exceeds an Odds Ratio=1.5, this constitutes sufficient evidence to warrant subsequent investigation. M=1000 Monte Carlo simulations, using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 81.9% of the time. Data analyses. The data analytic strategy will use generalized linear mixed and structural equation modeling (SAS 9.4, R v. 3.4, Stan,v. 2.17 and MPlus v. 8.3) for both continuous and discrete outcomes. All analyses will be conducted on an intention-to-treat basis. To address missingness, Bayesian approaches will implement joint modeling of observed outcomes and the missing data which is robust to ignorable missingness (i.e., MCAR and MAR). Sensitivity analyses will evaluate robustness of analytic conclusions to missing data. Non-ignorable missing data patterns (i.e., MNAR) will be addressed through pattern-mixture modeling methods.Specification of diffuse, neutral priors will reflect the initial uncertainty regarding effect sizes. For all generalized linear mixed models, priors for regression coefficients will be specified as ~Normal (µ=0, σ2=1 x 106) (for non-normal outcomes this refers to the prior for the coefficient within the link function), level one error variances will be specified as ~Inverse Gamma (shape=0.001, scale=0.001). Choice of prior distribution for level two variances will follow Gelman's recommendations. Bayesian Structural Equation Modeling (BSEM) prior specification will adapt recommendations from Muthén and Asparouhov 230. Priors for the comparison of proportions will be specified as ~Beta (α=0.5, β=0.5). Similar procedures will be used in secondary analyses to investigate subgroups of youth using specific substances (i.e. alcohol and marijuana), as well as intervention effects as a function of baseline readiness to change as a potential moderator. Mediational modeling will examine the degree to which putative mechanisms of behavioral change transmit the effects of the intervention on the specified outcomes. BSEM will investigate mediation of treatment effects due to CT on SEP and HIV/STI risk at 9 months by hypothesized mechanisms (processes of change, cognitive self-regulation, and confidence and temptation) measured at 3 months utilizing MPlus v. 8.3. Examination of the posterior distribution of the indirect effects will evaluate the probability that mediational effects exist. Specific Data Analyses - Hypothesis 1: CT, compared to Attentional Control (AC) AC will be associated with reduced risk of SEP and HIV/STI at 9-months post intake. The primary outcome is reduced risk of SEP and HIV/STI at 9 months, however at each time point (3-, 6-, and 9-month) multilevel logistic models will evaluate the risk of SEP and HIV/STI as a function of treatment condition while addressing clustering due to forensic program assignment. At each time point generalized linear multilevel models will evaluate the presence/absence of risk drinking, presence/absence of marijuana use, presence/absence of vaginal intercourse without effective contraception, and presence/absence of vaginal or anal intercourse without condom use as a function of treatment condition while addressing clustering due to forensic program assignment. Hypothesis 2: Compared to AC, CT will improve cognitive self-regulation abilities at 3-, 6-, and 9-month post intake as measured by self-report self-regulation measures. At each time point (3- and 9-month) generalized multilevel linear models will evaluate self-regulation as a function of treatment condition while addressing clustering due to forensic program assignment. Hypothesis 3: The processes of change, confidence and temptation, and cognitive self- regulation, for each risk behavior at 3-months will mediate the effect of treatment on SEP risk and HIV/STI risk at 9-months post intake for CT. Multilevel Bayesian structural equation modeling (M-BSEM) will evaluate the degree to which processes of change, cognitive self-regulation, confidence and temptation measured at 3 months follow-up mediate the effect of treatment on SEP and HIV/STI risk at 9 month follow-up. Multilevel elements will address clustering as a function of forensic program assignment. Multigroup analyses testing the mediation models will find invariance between Non-Hispanic Black, Hispanic, and Non-Hispanic White. Hypothesis 4: Female youth with low baseline readiness to change risk behavior will have less risk of SEP and HIV/STI at 3-, 6- and 9-months post intake in the CT intervention condition, designed to increase motivation and goal striving, than female youth with low baseline readiness to change risk behavior in the AC condition. At each time point (3-, 6-, and 9-month) multilevel logistic models will evaluate the risk of SEP and HIV/STI as a function of treatment condition, baseline readiness and the interaction of treatment and baseline readiness. These models will use the approach advocated by Simon and Dixon. Sample Size. The investigators anticipate recruiting N=435 with 92% retention based on our experience with Project CHOICES, CHOICES Plus, and CP-T yielding a final sample size for analyses of N=400. Randomization, stratified by program, will result in n=200 participants per condition with participants clustered within k=4 forensic program assignments. Investigators assume a conservative ICC = 0.20 due to clustering. Absolute risk reductions in risk of SEP range from 14.8% to 25.1% based on Project CHOICES, Project CHOICES Plus and our pilot CHOICES-TEEN. For the purposes of sample size justification, investigators will assume N=435 randomized in 1:1 fashion (minimum 400 completers), stratified by program, and ICC = 0.20 and a conservative estimate of an ARR=15% for reduced risk of SEP and HIV/STI. Finally, investigators stipulate that if the posterior probability that there is an effect of treatment (Odd Ratio>1.0) is greater than 0.75 and that the median treatment effect estimate exceeds an Odds Ratio=1.5, this constitutes sufficient evidence to warrant subsequent investigation. M=1000 Monte Carlo simulations, using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 81.9% of the time.

    Phase

    N/A

    Span

    208 weeks

    Sponsor

    Baylor University

    Houston, Texas

    Recruiting

  • Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

    Phase

    2

    Span

    159 weeks

    Sponsor

    Innolife Co., Ltd.

    Houston, Texas

    Recruiting

  • A Study of Baricitinib in Participants With Rheumatoid Arthritis

    Phase

    4

    Span

    324 weeks

    Sponsor

    Eli Lilly and Company

    Houston, Texas

    Recruiting

  • A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

    Phase

    3

    Span

    192 weeks

    Sponsor

    Janssen Research & Development, LLC

    Houston, Texas

    Recruiting

  • Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

    The COVID-19 pandemic is having a profound impact on children globally, jeopardizing their sense of safety, security, and behavioral health. In addition to COVID-19, millions of children are still recovering from recent hurricanes that struck the southern the United States. Children exposed to climate-induced disasters (e.g. hurricanes) are at a significant risk for mental and behavioral health challenges. Coupled with an enduring pandemic, many of these children are disproportionately at risk for escalating mental health problems. Racial and ethnic minority children who live in socioeconomically disadvantaged neighborhoods are among the most vulnerable during and after large-scale disasters. They are more likely experience high levels of social and material losses, displacement, and lack of access to mental and physical health services. Thus, there is a critical need for these children to received accessible, empirically supported preventative interventions to mitigate the onset of mental illness and behavioral health issues. Most post-disaster behavioral health interventions are designed to treat rather than prevent mental health conditions and are often inaccessible to racial and ethnic minority children living in socioeconomically disadvantaged communities. The present study, therefore, seeks to examine the implementation and efficacy of the COVID-19 adaptation of a disaster focused empirically supported prevention intervention, the Journey of Hope (JoH), distributed by Save the Children, a humanitarian organization serving socioeconomically disadvantaged and racial and ethnic minority children in communities dually impacted by COVID-19 and recent hurricanes that struck the Southern United States. The long-term goals of this study are to: (1) respond to the critical need of accessible behavioral health interventions designed to prevent and/or reduce COVID-19 related distress; and (2) provide an understanding on how a COVID-19 tailored prevention intervention mitigates behavioral health disparities among racial and ethnic minority children in high poverty settings who have been exposed to multiple large scale disasters. In a pragmatic randomized control trial with 800 children between 3-8th grade, we seek to: Aim 1: Evaluate the efficacy of the COVID-19 adapted JoH (JoH-C19) in preventing behavioral health and interpersonal problems among socioeconomically disadvantaged and racial and ethnic minority children who have been exposed to multiple large-scale disasters relative to a healthy life-style attention control condition. Aim 2: Examine if hypothesized mechanisms of change variables (social connectedness, adaptive coping, self-efficacy) mediate intervention effects (JoH-C19 vs attention control) on child individual behavioral health and interpersonal outcomes. Aim 3: Assess the moderating impact of COVID-19 related stressors on behavioral health outcomes among children who participate in JoH-C19 versus the control condition. Aim 4: Explore implementation barriers, facilitators, and acceptability of the JoH-C19 within school and after-school settings and delivered by community and school-based counselors.

    Phase

    N/A

    Span

    216 weeks

    Sponsor

    University of Illinois at Urbana-Champaign

    Houston, Texas

    Recruiting

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