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NCT ID: NCT04484077 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

hCT-MSC Infusion in Adults With Autism Spectrum Disorder

AIMs
Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of a single intravenous dose of Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in adults with autism spectrum disorder (ASD). hCT-MSC is a cell product isolated from umbilical cord tissue. The cells from the cord tissue are processed and expanded in the laboratory and then infused intravenously in a single dose per participant. Participants will be ages 18-35 years, with ASD and a full-scale IQ >70 without an identified genetic cause of autism. Participants will have an in-person baseline visit and remote follow up visits at 6 and 12 months. In addition to the primary endpoints evaluating safety, the study will evaluate changes in social communications skills after hCT-MSC administration.

NCT ID: NCT04483778 Active, not recruiting - Melanoma Clinical Trials

B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Start date: July 13, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a B7H3-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express B7H3. On Arm A of the study, research participants will receive B7H3-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at B7H3 and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. Arm A CAR T cells include the protein EGFRt and Arm B CAR T cells include the protein HER2tG. These proteins can be used to both track and destroy the CAR T cells in case of undue toxicity. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the participant's body on each arm. Participants will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Participants who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.

NCT ID: NCT04483544 Active, not recruiting - Cervical Cancer Clinical Trials

Pembrolizumab and Olaparib in Cervical Cancer Patients

Start date: December 3, 2020
Phase: Phase 2
Study type: Interventional

The study is a non-randomized, open-label phase II clinical trial to test the investigational combination of the drug pembrolizumab with the drug olaparib in patients diagnosed with advanced or recurrent cervical carcinoma after standard chemotherapy.

NCT ID: NCT04483440 Active, not recruiting - Choroideremia Clinical Trials

Dose Escalation Study of Intravitreal 4D-110 in Patients With Choroideremia

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

This study will evaluate safety, tolerability, and preliminary efficacy of a single intravitreal (IVT) injection of a recombinant adeno-associated virus (AAV) gene therapy, 4D-110, in male patients with genetically-confirmed Choroideremia (CHM).

NCT ID: NCT04483011 Active, not recruiting - Metabolic Syndrome Clinical Trials

The Safety and Efficacy Study of RiaGev in Healthy Adults

Start date: October 25, 2019
Phase: N/A
Study type: Interventional

This current randomized, double-blind, comparator-controlled, cross over study investigates the efficacy and safety of RiaGev™ via evaluation of NAD+, ATP, glucose, insulin, glutathione, and cortisol levels in healthy adults of ages 36-65.

NCT ID: NCT04482686 Active, not recruiting - Covid-19 Clinical Trials

Trial of Combination Therapy to Treat COVID-19 Infection

Start date: December 9, 2020
Phase: Phase 1
Study type: Interventional

In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.

NCT ID: NCT04482673 Active, not recruiting - COVID-19 Clinical Trials

Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection

VitD-COVID19
Start date: July 31, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.

NCT ID: NCT04482647 Active, not recruiting - COVID-19 Infection Clinical Trials

Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic

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

This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Breathing techniques and medication may help manage stress and improve lung health. The goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the COVID-19 pandemic.

NCT ID: NCT04482621 Active, not recruiting - COVID-19 Clinical Trials

Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial

DART
Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a total of 40 patients) to assess efficacy of decitabine in the treatment of critically ill patients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receive standard of care plus Decitabine or standard of care plus saline based placebo. The primary objective is to determine safety and efficacy of decitabine for COVID-19 ARDS based on clinical improvement on a 6-point clinical scale.

NCT ID: NCT04482582 Active, not recruiting - Rib Fractures Clinical Trials

Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients

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

The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity