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NCT ID: NCT06260774 Not yet recruiting - Clinical trials for Advanced Solid Tumor

Study of TTX-MC138 in Subjects With Advanced Solid Tumors

Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors

NCT ID: NCT06260683 Not yet recruiting - Clinical trials for Cigarette Smoking-Related Carcinoma

A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health.

NCT ID: NCT06260059 Not yet recruiting - Heart Failure Clinical Trials

Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

EmpaCHD
Start date: February 2024
Phase: Phase 4
Study type: Interventional

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).

NCT ID: NCT06260033 Not yet recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

Start date: June 11, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment. This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.

NCT ID: NCT06259409 Not yet recruiting - Surgical Wound Clinical Trials

Regenn® Therapy System Safety Study

Start date: May 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: - The device-related serious adverse event rate. - Patient post-operative pain as assessed using a validated pain measurement scoring system. - The number and type of adverse events. - The rate of delayed seroma formation. Participants will - Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications. - Undergo a physical exam, an assessment of patient vital signs and routine blood analyses. - Complete an Informed Consent Form if selected to participate in the investigational study. - Be randomly assigned to the different study arms. - Not change the operation of their respective device or to disturb components of their device. - Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device. - Attend two post-operative visits at approximately one month and three months.

NCT ID: NCT06258941 Not yet recruiting - Healthy Volunteers Clinical Trials

The Effects of 12-Week High-intensity Interval Training With Mindfulness-based Recovery on Executive Function, Fitness, and Mindfulness in Children

Start date: June 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 10-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities. Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases. During the pretest phase, participants an their parents will complete the following 1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient 2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index 3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness 4. Computerized tasks to assess EF 5. Parent-reported demographic and health information Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit. Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again. Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF. Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.

NCT ID: NCT06258837 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

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

The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.

NCT ID: NCT06258525 Not yet recruiting - Colorectal Cancer Clinical Trials

SAMe in Prevention of Oxaliplatin-associated Liver Injury

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

This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.

NCT ID: NCT06257693 Not yet recruiting - Clinical trials for Prostate Adenocarcinoma

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

Start date: February 2024
Phase: Phase 1
Study type: Interventional

The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.

NCT ID: NCT06257537 Not yet recruiting - Arthritis Clinical Trials

Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

Start date: February 19, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.