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NCT ID: NCT06421935 Not yet recruiting - Clinical trials for Advanced Solid Tumor

M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501)

Start date: July 1, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 as monotherapy or in combination with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.

NCT ID: NCT06421350 Not yet recruiting - Clinical trials for Complex Regional Pain Syndromes

Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

Start date: June 2024
Phase: N/A
Study type: Interventional

The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

NCT ID: NCT06421155 Not yet recruiting - Acute Leukemia Clinical Trials

Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

The survival of children, adolescents and young adults (AYA) with acute leukemia has improved dramatically over the last two decades. This success is a result of using multiple chemotherapy drugs in combination, with the inclusion of drugs that enter the brain and prevent leukemia cells from growing there. Studies in these cancer survivors have shown that the exposure to these chemotherapy drugs can lead to risks for impaired brain function, also referred to as neurocognitive side effects of chemotherapy. There is an opportunity to identify participants at risk for these side effects and to prevent their development. The purpose of this study is to incorporate a brain imaging tool known as Magnetic Resonance Fingerprinting (MRF) to look for brain matter changes in acute leukemia participants receiving chemotherapy. The MRF scan will be performed at diagnosis and repeated at multiple times during the entire therapy duration as well as at defined intervals after therapy is complete. Investigators would also do an electronic test of memory and brain function (cognitive function), which would be administered in a gaming format on iPads or a similar device. The goal will be to correlate results of MRF imaging with the tests of cognitive function. The benefits of this imaging technique include that it can be done quickly (in minutes), it is non-invasive, it is resistant to motion-artifacts and it can be easily repeated for comparison purposes. The advantages of the cognitive test include its short duration of 20 minutes and its gaming format making it friendly for children to use.

NCT ID: NCT06420661 Not yet recruiting - Type 1 Diabetes Clinical Trials

School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes

SPACE
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.

NCT ID: NCT06420557 Not yet recruiting - Phobia Clinical Trials

Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement

DecNef
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This application investigates the efficacy of a novel method of neuro-reinforcement based on decoded fMRI activity to reduce fear responses in individuals with phobias (e.g., spiders, snakes). This method works unconsciously in the brain, without the need for participants to endure repeated conscious exposures to their feared stimuli. Fear-related disorders such as specific phobia, post-traumatic stress disorder (PTSD), and other anxiety disorders present a major challenge, as effective treatment options usually involve repeated exposures to feared stimuli, leading to high levels of distress, fear, and panic that can motivate premature treatment termination. Consequently, there is an unmet need for treatment that minimizes subjective discomfort and attrition in order to maximize efficacy. Recent developments in computational neuroimaging have enabled a method that can deliver unconscious exposure to feared stimuli, resulting in effective fear reduction while bypassing a primary cause of treatment attrition. Because this treatment method happens unconsciously in the brain, changes in behavior outcomes are potentially more likely to generalize to different contexts, thereby overcoming a limitation of traditional treatments.

NCT ID: NCT06420492 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of Novel Therapeutics for Acute Remedy of Colitis

SHARC
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.

NCT ID: NCT06420375 Not yet recruiting - Ulcerative Colitis Clinical Trials

Treatment of UC With Novel Therapeutics

TURTLE
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study.

NCT ID: NCT06420336 Not yet recruiting - Opioid Use Clinical Trials

QL vs LAI for Palatoplasty

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

NCT ID: NCT06420167 Not yet recruiting - Clinical trials for Renal AL Amyloidosis

DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

FLORAL
Start date: May 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis using a decentralized study design. Participants will be: - screened for the trial via an online platform - contacted by study personal to obtain electronic consent - enrolled in the trial if eligible and consented - contacted by study personal for further instructions and directions - sent dapagliflozin oral medication (supplied by the site pharmacy) - followed up regularly with the study team via telemedicine or other online avenues - monitored using lab work, inquiries about side effects and assessment of protocol adherence at 1 month, 3 months and 6 months - continue treatment for 6 months

NCT ID: NCT06420089 Not yet recruiting - Clinical trials for T Cell Non-Hodgkin Lymphoma

CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)

VIPER101
Start date: June 30, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.