El Draguillo

Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.

Researchers are evaluating the safety, tolerability, how the body processes pharmacokinetics, how the body responds pharmacodynamics, and effectiveness of TERN-701, a selective inhibitor targeting BCR-ABL1, in adults with chronic phase chronic myeloid leukemia who have received prior treatment. This Phase 12 trial focuses on participants with treatment challenges such as resistance or intolerance to previous therapies. The study is sponsored by Terns, Inc. and aims to better understand TERN-701s impact in this patient group. The trial has two main parts. Part 1 involves dose escalation where participants receive increasing doses of TERN-701 once daily to determine safe and effective dose levels. Part 2 includes randomized dose expansion cohorts to further assess safety and efficacy at two selected doses from Part 1, and an additional mutation cohort Part 2m evaluating a specific 500 mg dose in participants with certain resistance mutations. Treatment is given continuously in 28-day cycles with scheduled clinic visits at specified days during the first cycle and then on Day 1 of subsequent cycles. Participants will be closely monitored through regular visits for safety, tolerability, and response to treatment. Researchers will evaluate dose-limiting toxicities, adverse events, hematologic and molecular responses, and changes in BCR-ABL1 transcript levels over up to three years. Approximately 180 participants are expected to enroll, contributing to comprehensive data collection on TERN-701s performance and safety in this chronic leukemia population.

Researchers are evaluating Enzomenib DSP-5336, an oral drug, in patients with various types of acute leukemia, including relapsed or refractory acute myeloid leukemia AML, acute lymphocytic leukemia ALL, and acute leukemia of ambiguous lineage. The study also includes patients with high-risk myelodysplastic syndromes MDS and relapsed multiple myeloma MM in selected sites. This phase 12 trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and clinical activity of DSP-5336 alone or combined with standard AML treatments, particularly in patients with specific genetic mutations like MLL rearrangement or NPM1 mutation. The study involves dose escalation and dose expansion of DSP-5336 administered orally. Participants may receive DSP-5336 alone or combined with standard AML regimens such as venetoclax plus azacitidine or intensive chemotherapy with cytarabine and daunorubicin 73. Different study arms include patients with or without certain medications like CYP3A4 inhibitor azoles, and those with specific genetic profiles. The trial evaluates recommended phase 2 doses for various patient groups and combination treatments. Participants will undergo assessments including monitoring for adverse events within 30 days after the last dose and evaluation of clinical responses approximately six months after treatment begins. Researchers will collect blood and bone marrow samples for genomic analysis and track drug levels in the body. Safety labs, ECGs, physical exams, and patient questionnaires will be performed throughout the study. The trial includes long-term follow-up of overall survival up to two years after treatment ends, with visits and tests scheduled to monitor health and treatment effects.

Researchers are evaluating ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer NSCLC whose tumors show high PD-L1 expression. This phase 3 study compares ivonescimab to pembrolizumab, focusing on overall survival and progression-free survival to understand which treatment may better support patients with this condition. Participants will be randomly assigned to receive either ivonescimab or pembrolizumab through intravenous injection. The study is double-blinded and multiregional, involving continuous treatment and monitoring for up to approximately 36 months. Both groups receive their assigned treatment regularly during this period, with careful observation of treatment responses and side effects. During the trial, participants will undergo evaluations including scans to measure tumor size, laboratory tests, and assessments of adverse events. Researchers will track overall survival, progression-free survival, response rates, disease control, and duration of response. Safety monitoring will continue for up to 24 months after the last dose. The total study period extends until June 2029, allowing long-term data collection on treatment effects and safety.

Gynecological cancers, including ovarian, uterine, and cervical cancers, pose a significant health challenge for women. Many survivors experience chronic pelvic pain caused by treatments like radiotherapy and chemotherapy, which can be difficult to manage and can greatly reduce quality of life. Researchers are studying how ozone therapy might influence gene expression and epigenetic markers to better understand and possibly predict pain relief in these patients. This observational and prospective study involves two groups of adult women with gynecological tumors treated by radiotherapychemotherapy those with chronic pelvic pain who receive compassionate or palliative ozone therapy, and those without this pain. No interventions beyond standard care are applied to the group without pain. The study aims to analyze differences between these groups at the start and after 16 weeks, focusing on gene expression and biological age assessed by epigenetic clocks. Participants will be assessed at baseline and after 16 weeks of ozone therapy if applicable. Researchers will measure gene expression, epigenetic biological age, pain levels, toxicity grades, quality of life, and biochemical markers of oxidative stress and inflammation. The study duration extends to August 2027, with comprehensive monitoring to evaluate the molecular and clinical effects of ozone therapy in managing treatment-induced chronic pelvic pain.

Chemotherapy-induced peripheral neuropathy CIPN is a common and distressing side effect of chemotherapy that often leads to dose reductions or interruptions, which can lessen treatment effectiveness and lower quality of life. This research is an observational study linked to a randomized clinical trial OzoParQT that explores how the gut microbiome relates to CIPN severity and response to rectal ozone therapy in adults with various tumors experiencing CIPN symptoms for at least three months. Participants receive standard care plus 40 sessions of rectal insufflation with either an O3O2 gas mixture ozone therapy gradually increasing in concentration or oxygen alone as a placebo, over a period of 16 weeks. The study compares gut microbiome profiles and symptom changes between those who experience improvement and those who do not, as well as between the ozone and placebo groups. During the 16 weeks, participants will provide stool samples and complete questionnaires assessing neuropathy severity, quality of life, anxiety, and depression. Researchers will also measure biochemical markers of oxidative stress and inflammation. The main outcomes focus on changes in gut microbiome and neuropathy symptoms, while secondary measures include quality of life and mental health assessments. The total project is planned to last 60 months.

Researchers are comparing the safety and effectiveness of the Myval Transcatheter Heart Valve THV Series with other contemporary valve devices, specifically the Sapien THV Series and Evolut THV Series, in patients with severe symptomatic native aortic valve stenosis. This prospective, randomized, multinational trial aims to determine if the Myval THV Series performs at least as well as these established valves for treating this condition. The study will enroll a total of 768 participants, with equal numbers receiving either the Myval THV or the contemporary valves. Participants will receive heart valve replacements via the transfemoral approach using valves sized appropriately for their anatomy. The Myval THV Series includes several device sizes ranging from 20 mm to 29 mm, while the comparator devices include Sapien and Evolut valves in various sizes. The trial also features a non-randomized nested registry to evaluate extra-large Myval valves 30.5 mm and 32 mm and a lead-in phase where investigators perform initial implantations to ensure protocol adherence before enrolling study subjects. Throughout the study, participants will be closely monitored with assessments of valve safety and effectiveness using criteria defined by the Valve Academic Research Consortium-3 VARC-3. Outcomes measured include mortality, stroke, kidney injury, bleeding, valve function, device success, and quality of life, among others, followed up to 10 years. The study includes detailed safety and efficacy evaluations at multiple time points, including pre-discharge, 30 days, 1 year, and longer-term follow-ups. Participants will undergo clinical evaluations, echocardiography, and quality of life questionnaires during these visits.

This research aims to collect detailed, long-term information about patients with Lysosomal Acid Lipase LAL Deficiency, a rare genetic disorder caused by a deficiency of the enzyme responsible for breaking down certain fats in the body. The condition can present as a severe and rapidly progressing disease in infants or a more chronic illness in children and adults, affecting the liver, spleen, and lipid levels, and leading to serious health complications including liver damage and cardiovascular risks. The study focuses on understanding the diseases natural history and variability to improve patient care worldwide. This is an observational, multi-center, international disease registry where patients diagnosed with LAL Deficiency, regardless of their treatment status, are followed over time. The registry collects real-world data to evaluate the long-term outcomes and effectiveness of treatments including sebelipase alfa. Participation is voluntary for both patients and physicians, and the study includes patients living with the disease as well as those deceased. Participants contribute data through their regular medical care and follow-up visits, with researchers gathering information about disease progression, treatment responses, and clinical outcomes. The primary goal is to enhance knowledge about LAL Deficiency by monitoring varied patient experiences and health changes over time. The study is ongoing and aims to support clinical practice and regulatory commitments related to sebelipase alfa therapy. The total duration of participation varies based on ongoing data collection.

This research aims to evaluate whether taking the Ovosicare4 Fertility food supplement helps increase the chance of becoming pregnant in women aged 32 to 38 years who have been trying to conceive for at least six months before starting supplementation. The study is observational and focuses on real-world use of this supplement containing a combination of MYODCI, antioxidants, vitamins, and minerals. Participants will follow a supplementation plan prescribed as part of standard clinical practice. The study does not require additional tests or extraordinary visits beyond those normally done in routine care. The observation period for each participant will last up to 18 months, but it may end sooner if pregnancy occurs. During the study, there will be a total of three visits. Women in the study will undergo routine assessments including blood tests for biochemical and hormonal panels, karyotype analysis, and ultrasound exams to monitor anatomy and follicle count. Researchers will track spontaneous pregnancy rates, time until pregnancy, safety, tolerability, satisfaction, and adherence to supplementation. Live birth rates will also be recorded after pregnancy confirmation. The study provides follow-up through 9 months after enrollment or until pregnancy.

Researchers are evaluating whether the combination of oral decitabine plus ivosidenib can treat adult patients with newly diagnosed acute myeloid leukemia AML who have the IDH1 R132 mutation. This study focuses on older adults over 60 years or adults over 18 years with certain health conditions that make them unsuitable for standard intensive chemotherapy. The trial aims to assess rates of complete remission and incomplete marrow recovery, as well as the frequency and severity of adverse events related to the treatment. Participants will receive treatment in 28-day cycles. Each cycle includes oral ivosidenib 500 mg daily for 28 days and oral decitabine-cedazuridine tablets on days 1 through 5. During screening and the first two treatment cycles, hydroxyurea or cytarabine may be used to control high white blood cell counts if needed. Patients who achieve remission may be eligible for an allogeneic stem cell transplant and can resume ivosidenib after 60 days post-transplant. The post-transplant treatment phase may last up to two years. During the study, participants will undergo regular assessments including monitoring for disease progression, side effects, and treatment response. Researchers will collect data on remission rates and adverse events for up to three years. Those undergoing stem cell transplants will have additional evaluations before and after transplant, including minimal residual disease status. Participant involvement may continue for the duration of the treatment cycles, transplant period, and follow-up visits, ending either with disease progression or study completion.