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Treatment Trial - ClinicalTrials.gov

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Last Updated: 06 July 2022

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Genomically-Guided Treatment Trial in Brain Metastases

As determined by response rate, it was determined that the effectiveness of a CDK inhibitor in patients with progressive brain metastases attributed to lung cancer, breast cancer, and other cancers harboring important genetic variations associated with sensitivity to CDK inhibitors. Determine the effectiveness of a PI3K inhibitor in patients with progressive brain metastases attributed to lung cancer, breast cancer, and other cancers harboring apparent genetic variations in the PI3K pathway, as determined by response rate. III. To determine the effectiveness of an NTRK/ROS1 inhibitor in patients with progressive brain metastases related to lung cancer harboring actionable NTRK/ROS1 gene fusions as determined by response rate. In each of the cohorts determined by disease and primary cancer type, the systemic response of Response Evaluation Criteria in Solid Tumors criteria was determined by medication and primary cancer type. In each of the cohorts determined by diagnosis and primary cancer type, Brain Metastases -RANO's central nervous system evaluated the clinical benefit rate in each of the cohorts determined by disease and primary cancer type. To determine the clinical benefit rate by RECIST for extracranial disease in each of the cohorts determined by diagnosis and primary cancer type. To determine the progression-free survival of intracranial disease in each of the cohorts determined by disease and primary cancer type. In each of the cohorts characterized by age and primary cancer type, we determine the toxicity profile of drugs in patients with brain metastases. Patients receive PI3K inhibitor paxalisib PO once a day on days 1-28. Patients are sent entrectinib PO QD on days 1-28 by ARM III : Patients are diagnosed with entrectinib PO QD.

Source link: https://clinicaltrials.gov/ct2/show/NCT03994796


European Society of Hypertension and Chinese Hypertension League Stroke in Hypertension Optimal Treatment Trial

In the lowest vs. higher LDL target group, the primary hypothesis is that recurrent stroke rates would be 25% lower in the lowest vs. intermediate SBP target group, 25% lower in the intermediate vs. higher SBP goal group, and 20% lower in the lower vs. higher target group. After corrections for repetitive measurements on the assumption that stroke incidence will be 4% per year in the highest SBP target group, the sample size has been estimated to yield a 80% power with a significance of 5%. Participants will be randomly allocated to one of three different sitting SBP goals: 145 to 135 mmHg 125 mmHg 125 mmHg to be achieved within 3 months and then maintained within the target window. paraphrasedl to be achieved within 3 months and then maintained within the target window, with a 2. 8 to 1. 8 mg/dl Lipid-lowering treatment plan and assigned therapy Participants randomly assigned to one of two specific LDL-C goals: A 2. 8 to 1. 8 mmol/l 110 to 70 mg/dl B 70 mg/dl. According to LDL-C at randomization and the LDL-C target, the initial statin dose should be chosen by the investigator. The initial dose can be increased or decreased to the maximum dose allowed in each country or cut until the LDL-C target is met perhaps within three months, and then adjusted up or down at 6-month intervals in order to maintain LDL-C within the randomized target window.

Source link: https://clinicaltrials.gov/ct2/show/NCT01563731


Pilot Study of Medication Adherence in Children, Adolescents, and Adults With Neurofibromatosis Type 1 (NF1) on Clinical Treatment Trials

Oral therapeutic options for the treatment of plexiform neurofibromas are being actively researched, but early clinical findings show that long-term medication adherence will be most likely for patients with several types of chronic disease, as well as those with NF1. Drug adherence is more reliable indicator of medication adherence in other patient populations than patient diaries or pill counts in other patient populations, according to medication event monitoring systems. This single-site, longitudinal study will recruit children and adults with NF1 diagnosis who are currently enrolled in a treatment protocol for a drug aimed at improving PN volume reduction. Objective: To establish the commodification of MEMSTM to monitor medication adherence in the NF1 population. Patients with MEMSTM cap results indicating 90 percent adherence at any study visit will be administered electronically, and doctors will be interviewed to determine what factors can influence decreased medication adherence and potential interventions that may be helpful.

Source link: https://clinicaltrials.gov/ct2/show/NCT03531814


A Multicenter, Open-Label, Withdrawal and Treatment Trial Assessing the Efficacy, Safety, and Tolerability of Doses of CERC-801 in Subjects With SLC35A2-CDG, a Disorder of Hypogalactosylation

All participants will be asked to stop their ongoing medical food D-galactose therapy and start a 6-week run-in period with CERC-801 at a dose of 1 g/kg/day on completion of the Screening Visit, and will begin with CERC-801 at a dose of 1 g/kg/day. Following the run-in period, subjects will begin a 6-week washout period in which no one will be taking CERC-801. During the washout process, participants will be closely monitored for clinical signs and symptoms related to or suspected of D-galactose therapy withdrawals. During the washout period, subjects will be required to monitor fasting blood glucose level by glucometer every day and if they have signs of hypoglycemia. The key laboratory measurements will be determined to establish a post-washout baseline based on symptoms, clinically relevant changes to laboratory procedures, or the conclusion of the 6-week washout period. Subjects will begin CERC-801 therapy with a dose of 1 g/kg/day for 24 weeks at this baseline. The most significant clinical laboratory parameter evaluation will be repeated as part of the efficacy evaluation at the end of 24 weeks. Participants with CERC-801 at a dose of 1. 5 g/kg/day following completion of the efficacy evaluation period will begin for a long-term safety follow-up period of 12 months. Before starting unregulated D galactose therapy, subjects must have biologically and genetically demonstrated SLC35A2-CDG, as well as at least one recent analysis of NPCRS and relevant laboratory test results.

Source link: https://clinicaltrials.gov/ct2/show/NCT05402384

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions