Woolloongabba%2525252525252525252520brisbane, Australia

Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective, Multicenter, Cohort Study

PRIMARY OBJECTIVE: I. Evaluate whether patients with low-risk endometrial cancer and isolated tumor cells (ITC) will have worse recurrence-free survival (RFS) than a historical cohort of similar patients with negative nodes. OUTLINE: This is an observational study. Patients undergo tissue sample collection and have their medical records reviewed on study.

Ozone Treatment in Paresthesia (numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy

Rationale Chemotherapy-induced peripheral neuropathy (CIPN) can lead to a decrease and/or interruption of chemotherapy treatment, limiting its efficacy and decreasing patients' quality of life. Therapeutic measures for CIPN are very limited in number and efficacy. Our previous experience has suggested the potential clinical usefulness of adjuvant treatment with ozone in patients with CIPN. The hypothesis of the trial is that ozone treatment will improve numbness and tingling symptoms in patients with CIPN. Primary objectives: To evaluate the effect of adding ozone to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN), Grade 2 (moderate symptoms and/or limitation in instrumental activities of daily living) or higher, on: 1. patients' self-perceived level of paresthesia 2. patients' self-perceived health-related quality of life (HRQoL). Secondary objectives: To evaluate (in patients with numbness and/or tingling secondary to CIPN) the effect of adding ozone to the usual management on: 1. the additional direct costs incurred in the application of ozone and evaluate the cost-effectiveness of the administration of ozone in these patients in comparison with the usual exclusive treatment. 2. the evolution of the sensory neuropathy 3. the evolution of the level of anxiety and depression, 4. the evolution of biochemical parameters related to oxidative stress and chronic inflammation. 5. the evolution of hyperspectral signatures obtained from hands and feet. 6. to evaluate the toxicity of rectal ozone treatment in these patients. Main trial endpoints. 1. Percentage of change from baseline in "numbness and tingling" self-perceived by patients at the end of follow-up (week 28 after the commencement of ozone treatment) 2. Change from baseline in "quality of life" (using the EQ-5D-5L questionnaire) self-perceived by patients at the end of follow-up (week 28 after the commencement of ozone treatment) Secondary trial endpoints. To evaluate the percentage of change from baseline in all the secondary objectives: - at the end of ozone treatment (weeks 16) - and at the end of follow-up (week 28) Trial design. Phase II-III randomized triple-blind clinical trial. The duration of each patient in the study will be 28 weeks: 16 weeks of treatment and 12 weeks of follow-up. The planned total duration of the project is 60 months. Trial population. 42 adult patients (>= 18 years old), with any tumor, with paresthesias (numbness and/or tingling) due to CIPN, grade of toxicity >= 2 (according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0), for >= 3 months. Intervention. All patients will receive the usual management and treatment for their symptoms + "40 sessions of rectal insufflation of O3/O2 gas mixture" in 16 weeks (3 or 2 sessions per week): - Ozone group, O3/O2 concentration increasing from 10 to 30 µg/mL (µg of O3 by mL of O2). - Control-placebo group, O3/O2 concentration = 0 µg/mL (this is: only O2).

Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients with Chronic Pelvic Pain Secondary to Cancer Treatment

While survival rates of gynecological cancers have improved, many women experience chronic pelvic pain as a consequence of cancer treatment, particularly radiotherapy and chemotherapy. This persistent pain often has neuropathic characteristics, and it can be challenging to manage, negatively impacting physical and emotional well-being and quality of life. Conventional pain management strategies for these patients often provide limited relief. In our experience, ozone therapy has emerged as a promising option for managing chronic pain in various conditions, including side effects of cancer treatment. While the clinical benefits of ozone therapy have been observed in preliminary studies, the underlying molecular mechanisms underlying its analgesic effect remain largely unknown. Understanding how ozone therapy influences gene expression and epigenetic modifications could facilitate the identification of genes involved in the differential response to ozone therapy and a potential way for personalized strategies for pain treatment. The aim of this prospective study is to analyze how ozone therapy modulates the expression of certain genes and its impact on epigenetic clocks, which could help predict pain response. Primary Objectives: In patients with gynecological tumors treated by radiotherapy/chemotherapy, To evaluate - among patients with or without chronic pelvic pain induced by treatment. - before and after ozone treatment in those patients treated because of pelvic pain induced by radiotherapy/chemotherapy. The potential differences in: 1. Gene expression. 2. Biological age based on epigenetic clocks: Secondary Objectives: Evaluate in those patients the potential relationship between gene expression and epigenetic clocks with: 1. Grade of toxicity 2. Pain score 3. Health-related quality of life, 4. Biochemical markers of oxidative stress and inflammation. Trial Design: This observational and prospective study will analyze data from two groups of patients with gynecological tumors treated with radiotherapy/chemotherapy: - A group of patients with chronic pelvic pain secondary to radiotherapy-chemotherapy, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment. - A group of patients without secondary chronic pelvic pain. Trial Population: Adult women (≥ 18 years old) with gynecological tumors treated with radiotherapy-chemotherapy. They will be analyzed into two different groups of patients: - A group of patients with chronic pelvic pain secondary to radiotherapy-chemotherapy, submitted to our Chronic Pain Unit for compassionate/palliative ozone treatment. - A group of patients without secondary chronic pelvic pain. Intervention. No intervention. The management of patients will be the standard of care in our hospital. Study Duration: The primary completion date is planned for 14/February/2027. The study completion date is planned for 14/August/2027

Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy (CT), often requiring dose reductions or treatment interruptions, which can compromise efficacy of the planned CT (limiting its efficacy). Additionally, CIPN usually decreases patients' quality of life. Unfortunately, effective treatments for CIPN are limited. Emerging evidence suggests potential benefits of rectal ozone therapy and points to a possible role of the gut microbiome in CIPN development and treatment response. This observational study, ancillary to the randomized clinical trial (RCT) OzoParQT (NCT06706544), investigates the relationship between gut microbiome composition and CIPN severity in patients receiving rectal ozone therapy. Primary Objectives: To evaluate if gut microbiome profiles differ between patients: 1. with and without symptomatic improvement of CIPN. 2. receiving rectal ozone therapy and those receiving placebo. Secondary Objectives: To evaluate the relationship between gut microbiome composition and: 1. Health-related quality of life, 2. Anxiety and depression, 3. Biochemical markers of oxidative stress and inflammation. Main Trial Endpoints. Changes from baseline at the end of ozone therapy (week 16) in: - Gut microbiome profile - Patient-reported numbness and tingling - Neuropathy severity (QLQ-CIPN20 scale) - Paresthesia toxicity grade (CTCAE v.5.0) Secondary Trial Endpoints. Changes from baseline at the end of ozone therapy (week 16) in: - Patient-reported quality of life (EQ-5D-5L questionnaire) - Quality of life (QLQ-C30 questionnaire) - Anxiety and depression levels (HADS questionnaire) - Biochemical markers of oxidative stress - Biochemical markers of inflammation Trial Design: This observational study will analyze data from patients enrolled in the randomized, triple-blind, placebo-controlled OzoParQT clinical trial (NCT06706544). Trial Population in the OzoParQT trial (NCT06706544): Adults (≥18 years) with any tumor type, experiencing CIPN-related paresthesias (numbness and/or tingling), with a toxicity grade ≥ 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0) for ≥ 3 months. Intervention in the OzoParQT trial (NCT06706544). All patients will receive standard care for their CIPN symptoms plus 40 sessions of rectal insufflation of an O3/O2 gas mixture over 16 weeks: - Ozone group: O3/O2 concentration increasing from 10 to 30 µg/mL - Control-placebo group: O2 only (0 µg/mL O3) Study Duration: Each patient will participate in this study (OzoParQTmicrob) for 16 weeks, concurrent with the ozone therapy intervention. The total planned project duration is 60 months.

A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.

CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Spanish Academy of Dermatology and Venereology (AEDV) Melanoma Registry

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025

Chronic Pain Unit in the absence or failure of standard treatment, or when the standard treatment is associated with high morbidity or high risk. Frequently, these patients present alterations in self-perceived health-related quality of life (HRQoL), anxiety, depression, and other symptoms. This study aims to evaluate in these patients the effect of adjuvant symptomatic/palliative ozone therapy on the HRQoL and the potential changes from baseline on several parameters after treatment. MAIN OBJECTIVES: To evaluate in these patients: 1) the clinical effect on the HRQOL of adding ozone to the standard treatment. SECONDARY OBJECTIVES: To evaluate in these patients changes from baseline on 2) anxiety and depression, 3) pain (if applicable), 4) grade of toxicity (if applicable), 5) requirements of invasive procedures for symptom management, 6) evolution of main symptoms, 7) evolution of oxidative stress and inflammation (if systemic ozone therapy). METHODOLOGY: Prospective and observational study of patients referred to our Chronic Pain Unit for symptomatic/palliative treatment with ozone therapy between 2022 and 2025. MAIN VARIABLE: 1) HRQoL through the EQ-5D-5L questionnaire SECONDARY VARIABLE: 2) anxiety and depression through the hospital anxiety/depression (HAD) questionnaire, 3) Pain through the visual analog scale (VAS), 4) grade of toxicity in cancer patients through the CTCAE v5.0 scale, 5) the number of invasive procedures required for symptom management, 6) self -reported percentage of symptom improvement, 7) biochemical parameters of oxidative stress and inflammation. Assessments at weeks: 0 (baseline), 16 (end of O3/O2 treatment, objective), 28 (12 weeks after the end of ozone), and 40 (24 weeks after the end of ozone, control) Length of treatment: as required; initially, planned 16 weeks. Follow-up: 24 weeks after finishing O3/O2 treatment. Planned length of the clinical trial: 49 months.