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NCT ID: NCT04482244 Active, not recruiting - Anxiety Clinical Trials

RCT of CBD for Anxiety in Advanced Breast Cancer

Start date: January 19, 2022
Phase: Phase 2
Study type: Interventional

This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: - Cannabidiol (CBD)

NCT ID: NCT04482179 Active, not recruiting - Alzheimer Disease Clinical Trials

Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease

Start date: February 19, 2020
Phase: Phase 1
Study type: Interventional

Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognition in subjects with Alzheimer Disease (AD), the investigators propose to study the effectiveness of TMS as a therapy for impaired verbal communication. The hypothesis to be tested is that TMS combined with Constraint Induced Language Therapy (CILT) improves verbal communication more than sham TMS and CILT. A second aim is to use state-of-the-art neuroimaging to understand the mechanisms underlying any beneficial effect of the treatment.

NCT ID: NCT04481451 Active, not recruiting - Pain, Postoperative Clinical Trials

Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO

Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

This study proposes to evaluate the efficacy of single shot erector spinae block (ESB) versus single shot quadratus lumborum block (QLB) when used in conjunction with continuous lumbar plexus block (LPB) for postoperative analgesia in children and adolescents undergoing unilateral hip surgical procedures. The aim of this study is to compare the efficacy of the QL vs. ESP blocks as supplements to the lumbar plexus block with respect to pain control outcomes after hip PAO surgery. Both blocks are safe and easy to perform. There is currently no comparative, prospective data concerning the use of these two blocks for hip surgery. The investigational hypothesis is that there will be no clinical difference in the amount of opioid consumed or the overall pain control offered by these two block options.

NCT ID: NCT04481204 Active, not recruiting - Clinical trials for Borderline Resectable Pancreatic Adenocarcinoma

New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study

Start date: April 18, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.

NCT ID: NCT04481113 Active, not recruiting - Clinical trials for Anatomic Stage II Breast Cancer AJCC v8

Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

Start date: June 7, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2 negative. Abemaciclib may stop the growth of tumor cells by blocking certain proteins called cyclin-dependent kinases, which are needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working so tumor cells can't repair themselves and grow. Giving abemaciclib and niraparib together before surgery may make the tumor smaller.

NCT ID: NCT04481035 Active, not recruiting - Neurofibromatosis 1 Clinical Trials

Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1

NF1NAC
Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

Children with neurofibromatosis type 1 (NF1) commonly suffer from the effects of cognitive, behavioral, and motor impairments. At present there is no specific treatment for this NF1 complication. However, data from rodent models of NF1 along with uncontrolled clinical observations in children with NF1 suggest that the anti-oxidant, glutamate modulating compound N-Acetyl Cysteine (NAC) may reduce these impairments. Of particular interest is a murine study analyzing the central nervous system manifestations of NF1 at our institution. That study revealed a role for myelin-forming oligodendrocytes in the control of nitric oxide synthases (NOS) and their product, nitric oxide, in maintenance of brain structure and function, including regulation of behavior and motor control. Treating these mice with NAC corrected cellular and behavioral abnormalities. N-Acetyl Cysteine is available over the counter and has been used by thousands of individuals; moreover, it has shown some promise in clinical trials for psychiatric disorders. In order to better understand treatment mechanisms, and possibly predict long-term outcomes, the investigators propose concurrently to explore Specific Aim 1 (1.1, 1.2, and 1.3) exploratory potential disease biomarkers as outlined below. The primary outcome of this study is motor function rated with the Physical and Neurological Examination for Subtle Signs (PANESS), a validated scale that consistently demonstrates significant impairments in children with Attention Deficit Hyperactivity Disorder (ADHD), and which our preliminary data suggest may demonstrate more extreme problems in children with NF1. The first exploratory biomarker is motor system inhibitory physiology, measured using Transcranial Magnetic Stimulation (TMS). Preliminary measures in our NF1 population also show abnormalities similar to established findings in ADHD. The second exploratory biomarker is metabolomics profiling for the biomarker of oligodendrocyte dysfunction in NF1 participants: autotaxin. Preliminary data in our NF1 population showed specific signal abnormalities in the NF1 population compared to healthy controls. Therefore, the investigators propose to perform a double-blind placebo controlled, prospective, Phase IIa study to explore safety, tolerability, and efficacy of NAC on learning and motor behavior in children with NF1 aged 8 through 16 years old.

NCT ID: NCT04480671 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy

MERIT
Start date: August 26, 2020
Phase: N/A
Study type: Interventional

This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus. An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.

NCT ID: NCT04480567 Active, not recruiting - Clinical trials for Phenylketonuria (PKU)

AAV Gene Therapy Study for Subjects With PKU

Start date: September 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, dose escalation study to evaluate the safety, efficacy and tolerability of BMN 307 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of BMN 307 and will be followed for safety and efficacy.

NCT ID: NCT04480502 Active, not recruiting - Clinical trials for Undifferentiated Pleomorphic Sarcoma

ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

ENVASARC
Start date: December 9, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.

NCT ID: NCT04480255 Active, not recruiting - Premature Birth Clinical Trials

NICU2HOME+: Supporting Illinois Families

Start date: August 3, 2020
Phase: N/A
Study type: Interventional

The purpose of this project is to provide a stepwise, methodical approach to developing and testing the ability of Neonatal Intensive Care Unit 2 Home (NICU2HOME+) to support diverse Illinois families of premature infants during and after their Neonatal Intensive Care Unit (NICU) stays in an effort to address health equity, improve parenting, and reduce costs. There are 3 objectives of the study: 1) Identify and assess the requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement applications with Electronic Medical Record (EMR) integration that is culturally appropriate and customized to the needs of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2) develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective in: a) addressing health equity issues, b) improving parenting self-efficacy and satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower readmission rates that result in lower healthcare costs. All research recruitment and participation will take place in the following spaces: 1. Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices 2. Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices 3. Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices