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NCT ID: NCT04447027 Active, not recruiting - Clinical trials for Peripheral T-Cell Lymphoma

Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies

Start date: December 17, 2020
Phase: Phase 1
Study type: Interventional

Background: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective. Primary Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM. Other (Secondary) Objective: Measure the activity of this combination treatment. Eligibility: People age 18 and older who have a failed or relapsed after standard treatments for mature TCMs. Design: Participants will be screened for eligibility by performing the following tests or procedures: Physical exam Medical history Medicine review Blood and urine tests Symptom review Bone marrow examination Total Body imaging scans or x-rays Tumor biopsy Participants will have blood tests during treatment to make sure their blood cell counts are okay. Romidepsin is infused through an IV placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth. Participants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly. Participants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture. Participants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatment is working. Participants will also be asked to give blood, saliva, and sometimes have optional biopsies of their tumor where these tests are done for research purposes. After they have completed the protocol treatment (6 cycles), they will be asked to return to clinic 30 days after treatment has ended, then every other month (or 60 days) for the first 6 months, then every 3 months (90 days) for 2 years, and then every 6 months for years 2 to 4 after completing treatment. After 4.5 years, they will be seen once a year.

NCT ID: NCT04446728 Active, not recruiting - Pediatric Cancer Clinical Trials

Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer

PAT
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the social ecology, including patient and caregiver physical and psychosocial health. It is the strong recommendation from the first Standard of the Psychosocial Standards of Care in Pediatric Cancer that cancer centers engage in universal, systematic, psychosocial risk screening for newly diagnosed patients and their families. Universal screening at diagnosis fosters early identification of psychosocial risks and provides the opportunity to match psychosocial care to the level of family need for more equitable, effective and integrated services. However, few programs offer such care in an efficient, comprehensive, and consistent manner, potentially resulting in insufficient care that magnifies inequities in outcomes. To support pediatric cancer centers in their goal of meeting the first Standard of Psychosocial Care, this study will compare two implementation strategies for the Psychosocial Assessment Tool (PAT), a validated parent report screener of family psychosocial risk in English and Spanish, in a cluster randomized trial across 18 pediatric cancer programs in the United States.

NCT ID: NCT04446481 Active, not recruiting - Clinical trials for Mild Cognitive Impairment

Neurofeedback to Aid Vets' Memory

TUNe
Start date: February 5, 2022
Phase: N/A
Study type: Interventional

Military deployment is associated with increased risk of mild cognitive impairment (MCI). Combat stress related memory deficits has been well documented. Mild cognitive impairment such as memory deficits are the most common and earliest symptoms of Alzheimer's disease and related dementia (ADRD). The complaints about declined memory are common in healthy and cognitively intact civilian older adults, but less understood in aging Veterans. Brain training strategies to enhance cognitive skills and especially memory processes are unmet needs in aging Veterans who are at additional risk for MCI induced by ADRD. Since currently there is no effective drug treatment to stop cognitive decline, non-invasive brain training to boost memory functions in older Veterans is an increasingly attractive option to attenuating decline in memory.

NCT ID: NCT04446117 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

CONTACT-02
Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

NCT ID: NCT04445792 Active, not recruiting - Depression Clinical Trials

A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)

ADOPT PGx
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. Each trial is listed individually on clinicaltrials.gov and includes "PRO00104948" within the Unique Protocol ID: PRO00104948_A - Acute Pain Trial - NCT05966129 PRO00104948_B - Chronic Pain Trial - NCT05966142 PRO00104948_C - Depression Trial - NCT05966155 Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant therapy will reduce depression symptoms in participants who's body processes some anti-depressants faster or slower than normal.

NCT ID: NCT04445220 Active, not recruiting - COVID-19 Clinical Trials

A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy

Start date: November 19, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.

NCT ID: NCT04445025 Active, not recruiting - Infertility Clinical Trials

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Start date: September 1, 2020
Phase: Early Phase 1
Study type: Interventional

Patients who have been previously surgically diagnosed with endometriosis and have embryos predicted to be euploid after in vitro fertilization will be divided into 2 groups via randomization. The test group will receive Elagolix for 60 days prior to starting frozen embryo transfer preparation. The control group will be given leuprolide acetate every 28 days x 2 prior to starting the frozen embryo transfer preparation. Comparative implantation rates between two groups of patients will be evaluated

NCT ID: NCT04444518 Active, not recruiting - Pregnancy Related Clinical Trials

Increasing Influenza and Tdap Vaccination of Pregnant Women

Start date: November 11, 2020
Phase: N/A
Study type: Interventional

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

NCT ID: NCT04444245 Active, not recruiting - Hormone Disturbance Clinical Trials

Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF

OVAR-REJUV
Start date: July 15, 2022
Phase: Phase 1
Study type: Interventional

Trial of imaging guided intra-ovarian injection to improve ovarian function in clinical settings of Premature Ovarian Failure, Perimenopausal and /or early postmenopausal symptomatology and related hormonal deficiencies. The study will compare the effectiveness of autologous Platelet Rich Plasma alone versus Stromal Vascular Fraction (tSVF and/or cellular stromal vascular fraction (cSVF) in combination with Platelet Rich Plasma as regards efficacy and duration of ovarian reactivation in women with acquired Premature Ovarian Failure, Menopausal, and Perimenopausal women.

NCT ID: NCT04444102 Active, not recruiting - Inflammation Clinical Trials

The Acute Impact of Yoga-based Stretching on Inflammation and Its Resolution

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

The goal of this study is to explore the impact of two types of yoga-based body stretching (mild and intense) on dynamic changes of Systemic Inflammatory Cytokines (SICs) and Specialized Pro-resolving Mediators (SPMs) in yoga-naïve subjects.