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Central Nervous System clinical trials

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NCT ID: NCT05460871 Terminated - Clinical trials for Osteo Arthritis Knee

Pregabalin for Central Sensitization in TKA

Start date: February 21, 2023
Phase: Phase 4
Study type: Interventional

The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Participants will be identified who are indicated for TKA. Interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet inclusion criteria and agree to participate, they will complete the informed consent before being randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. They will also be scheduled to have a pre-operative physical therapy (PT) appointment which will include tests and measures standard to PT. Tests will include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures. On the day of surgery participants will be asked about any adverse effects of study medication and determine need to withdraw from study. The post-operative plan will be reviewed, including dose of study medication. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA . All participants will complete standard of practice physical therapy. After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. The study pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average). At the 6 week post-operative visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine MME based on patient report of quantity of opioid medication used. A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.

NCT ID: NCT04644315 Terminated - Melanoma Clinical Trials

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

ALpha-T
Start date: May 24, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.

NCT ID: NCT03789149 Terminated - Clinical trials for Brain Metastases, Adult

Focal Intraoperative Radiotherapy of Brain Metastases

Start date: May 2, 2019
Phase: Phase 2
Study type: Interventional

Brain metastases (BM) are the most prevalent tumors of the central nervous system (CNS), with a ratio of 10: 1 in relation to primary tumors. In prospective studies, whole-brain radiotherapy (WBRT) reduced the risk of local recurrence after resection of brain metastases from 46-59% to 10-28%. Furthermore, WBRT reduces the incidence of new metastases and death from disease, but no apparent improvement in overall survival (OS). Due to the potential neurocognitive effects associated with WBRT compared to isolated focal approach, several authors have suggested delaying WBRT and perform focal adjuvant RT after resection of isolated BM. In this context, intraoperative radiotherapy (IORT) in the cavity after resection of BM may be an appealing option. The primary objectives of this study are to evaluate local control (LC) and the control of brain disease (LC associated with the absence of new distant BM) after IORT for one completely resected supratentorial BM in the presence of up to 10 lesions suggestive of BM.

NCT ID: NCT03711422 Terminated - Clinical trials for Non-small Cell Lung Cancer

Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

Start date: November 16, 2018
Phase: Phase 1
Study type: Interventional

Brain metastases occurs in up to 50% of patients with EGFR mutant NSCLC. Leptomeningeal disease is a subset of patients with brain metastases for which there remains an unmet need. This trial aims to evaluate the role of two dosing schedules of afatinib in management of leptomeningeal disease in EGFR mutant NSCLC, specifically to determine Central Nervous System (CNS) penetration of afatinib, as well as clinical activity. Patients will start on daily dosing initially followed by pulsed intermittent dosing should we observe no clinical activity. A secondary objective is to identify the resistance spectrum in leptomeningeal disease. It is anticipated that optimal dosing schedule of afatinib e.g. pulsed dosing may improve CNS disease control.

NCT ID: NCT01348607 Terminated - Fatigue Clinical Trials

Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

Start date: July 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more effective than a placebo in reducing daytime sleepiness in these patients. PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or modafinil to see how well they work compared with a placebo in treating young patients with excessive daytime sleepiness after cancer therapy.

NCT ID: NCT01006109 Terminated - Clinical trials for Central Nervous System

Recording and Modulation of Neuronal Mechanisms During Operant Conditioning: a MEG Study

Start date: October 22, 2009
Phase:
Study type: Observational

Background: - Most of the time, humans make decisions according to their consequences, especially if they will be beneficial, and will avoid or try to avoid doing an action if it has a bad outcome. The way that the brain prepares a movement has been studied in detail, but the way the brain makes decisions before carrying out an action is still poorly understood. Researchers are interested in learning more about the decision-making process and how it affects the brain. Objectives: - To record the activity of the brain during decision-making processes. Eligibility: - Healthy, right-handed volunteers between 18 and 40 years of age. Design: - Potential participants will have a screening visit with a medical history and neurological examination to determine eligibility. - This study requires seven visits: one magnetic resonance imaging (MRI) visit and 6 magnetoencephalography (MEG) recording visits. The MEG recording visits will include transcranial magnetic stimulation (TMS). All visits will be spaced at least 1 week apart. Total participation will last about 6 weeks. - Participants will have an MRI scan at the first study visit. - The MEG procedures will record brain activity during a series of computer tests involving winning or losing money. TMS will be performed during these visits, separate from the test....

NCT ID: NCT00010101 Terminated - Clinical trials for Central Nervous System Tumor, Pediatric

Genetic Study of Brain Tumors in Young Children

Start date: March 2001
Phase: N/A
Study type: Observational

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer. PURPOSE: Genetic study to understand how genes may be involved in the development of brain tumors in young children.