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NCT ID: NCT04214886 Active, not recruiting - Clinical trials for B-cell Lymphoma Refractory

CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies

Start date: December 31, 2019
Phase: Phase 1
Study type: Interventional

In this protocol, the investigators hypothesize that modifying the process of producing CAR+ T-cells can help to improve responses and reduce toxicities. Building on previous in vitro studies that have shown successful production of CAR+ T-cells using a new production approach, the investigators are now studying the ability to produce these CAR+ T-cells and determine how well they work in the clinical setting.

NCT ID: NCT04214834 Active, not recruiting - Clinical trials for Neonatal Opioid Withdrawal Syndrome

Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Start date: September 8, 2020
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid among infants receiving an opioid (defined as morphine or methadone) as the primary treatment for neonatal opioid withdrawal syndrome (NOWS).

NCT ID: NCT04214756 Active, not recruiting - Acute Pancreatitis Clinical Trials

Methodist Acute Pancreatitis Protocol

MAPP
Start date: April 5, 2014
Phase:
Study type: Observational

The overall goal of this ongoing registry study is to optimize initial evaluation and treatment of patients with AP according to recommended guidelines, the Methodist Acute Pancreatitis Protocol (MAPP), which were implemented in January 2015.

NCT ID: NCT04214418 Active, not recruiting - Clinical trials for Gastrointestinal Cancer

Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies

MEKiAUTO
Start date: February 12, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is for patients with an advanced cancer that carries a mutation in a gene called KRAS. Genes are parts of our DNA which carry instructions for a cell (the smallest component of an body part). In many cancers, the KRAS gene contains errors (mutations) which allows the tumors to grow. The purpose of this study is to determine if combination treatment with atezolizumab, cobimetinib, and hydroxychloroquine is safe, and if it will decrease the size of the tumor and prolong life in patients whose tumors contain this mutation. Cobimetinib and atezolizumab are both approved by the FDA for use in other cancers, but not in some cancer types being studied in this trial. Hydroxychloroquine is FDA approved to treat malaria and other conditions, but has also not been approved for these cancer types. Preliminary results have shown that this combination of drugs is effective at killing cancer cells and shrinking tumors in several KRAS-mutated cancers in animals.

NCT ID: NCT04214327 Active, not recruiting - Substance Abuse Clinical Trials

Strengthening Families Program Online

SFPonline
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

This Phase II SBIR tests a newly developed web-based online parenting skills training and youth drug prevention program based on the evidenced-based "Strengthening Families Program." The study design involves a three-condition parallel randomized control trial contrasting: (1) SFP Online, (2) SFP Home-use DVD/videos, and (3) Wait-Listed Controls. DELIVERY OF INTERVENTION: The intervention condition, SFP Online, is a highly interactive, multimedia condition testing a 10-session online program with two intersecting tracks, one for parents and one for youth. Both tracks involve completion of three mini-lessons per week delivered online for 10 weeks. For the parent track (biological parents, caregivers or legal guardians), each lesson entails learning nurturing parenting skills that strengthen family bonds, setting clear boundaries with positive discipline, and monitoring youth's social activities and emotional well-being. The youth lessons teach social competence-based skills and drug refusal skills. For both tracks, lesson material is scaffolded in an integrated fashion, with challenge quizzes and process evaluations interspersed throughout the lessons. Each track includes a gaming portion to increase engagement and reinforce lesson content through stealth learning. The SFP Home-use DVD/video series is an 11-session program with the same content as the online version, but is not interactive. It is viewed either online or using a DVD player at home. In the Wait-Listed control condition, parents receive emails with food recipes and nutritional information over the same 10-week period; while their children receive emails with riddles and puzzles. At the conclusion of a 2-month follow-up period the wait-listed controls receive the SFP Online intervention, thus doubling the size of the intervention treatment condition. A second design feature is the use of a non-inferiority trial (NIT) to empirically examine the efficacy of SFP Online when compared to the Home-use DVD/videos and Group Norms data. The Group Norms, which serve as a benchmark of SFP effectiveness, is a representative, demographically matched sample of n=1400 families drawn from a database of over 6,000 families that have taken the full 14-session traditional class format of SFP. Effects sizes, using the partial eta-squared statistic, will be compared between conditions for the major outcome measures.

NCT ID: NCT04214288 Active, not recruiting - Clinical trials for Advanced ER-Positive HER2-Negative Breast Cancer

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

SERENA-2
Start date: April 22, 2020
Phase: Phase 2
Study type: Interventional

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

NCT ID: NCT04214197 Active, not recruiting - Atopic Dermatitis Clinical Trials

Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

Start date: February 3, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to document the timing of improvement in atopic dermatitis symptoms and severity following the application of crisaborole ointment 2% in patients 2 years or older with mild to moderate atopic dermatitis. Crisaborole ointment 2% will be applied topically twice daily for four weeks and progress will be assessed by photography and patient-reports.

NCT ID: NCT04214067 Active, not recruiting - Clinical trials for Endometrial Endometrioid Adenocarcinoma

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer

Start date: April 9, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

NCT ID: NCT04213872 Active, not recruiting - Clinical trials for Cognitive Impairment

Gene Expression, Meditative Movement, and Emotional Distress (GME)

GME
Start date: July 17, 2017
Phase: N/A
Study type: Interventional

Study Title: Gene Expression, Meditative Movement and Emotional Distress (GME) Background and Objectives: Breast cancer survivors (BCS) often report decrements in cognitive functioning. Cognitive impairment (CI) is generally understood as resulting from chemotherapy or radiation, but may also result from chronic emotional distress experienced by breast cancer patients and survivors. Meditation and exercise are both known to reduce stress, with growing evidence for the potential of each to also improve cognitive functioning in cancer patients and survivors. A Meditative Movement (MM) program (Qigong/Tai Chi Easy) offers the potential of combining both benefits of meditation and exercise for breast cancer survivors. This is a pilot study, testing the MM program to effect changes in cognitive functioning and associated symptoms/conditions such as anxiety, depression, sleep quality and using gene expression factors as biomarkers to potentially measure the molecular signature of these changes. Forty BCS will be consented and assigned to an intensive eight week MM program. Cognitive functioning and associated symptoms/conditions will be assessed before and after the 8-week MM program to examine the participants' behaviors and symptoms. Peripheral blood samples will be collected before and after the 8-week MM program and will be analyzed for gene expression changes. If successful, this study may provide preliminary data for a full powered randomized control trial if results show promise in the psycho-behavioral outcomes and genomic expression results.

NCT ID: NCT04213846 Active, not recruiting - Clinical trials for Alcohol; Use, Problem

Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences

AMPS
Start date: January 6, 2020
Phase: N/A
Study type: Interventional

The proposed study will develop a smartphone/mobile app intervention that incorporates ecological momentary assessment (i.e., two brief surveys per day) and daily intervention messaging (2 messages per day) for three weeks to target high-risk alcohol use among young adult college students. The intervention mainly focuses on alcohol expectancies, alcohol use, and consequences and the daily associations between these and includes personalized intervention messages based on participants' own event-level expectations and experiences. Other psycho-educational alcohol-related content is also provided over the course of three week intervention. This mobile app intervention will be used in a randomized controlled trial (RCT) comparing young adult college students who receive the intervention with those who only receive assessments via the mobile app.