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NCT03502603
This study is aimed at investigating three new tests that will form part of a computerized tool designed to test brain/cognitive functioning. The system will be evaluated along with the tests' usability on samples of healthy controls and neurologically impaired patient participants. These new tests will be assessed with regard to reliability and validity. Reliability will be addressed through investigation of internal consistency of the test items. Validity will be evaluated relative to traditional paper-and-pencil tests and differentiation between patient and healthy participants.Each participant will complete both the computerized and paper and pencil-based tests. The results will be analyzed to see how performances on the two test types compare. The overall aim of this project is to determine if these new computerized tasks are an improvement over standard paper and pencil-based neuropsychological measures.
NCT01386710
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that the investigators seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. Additionally the investigators will analyze if a combination with IA Carboplatin will further improve the treatment response. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab with IV Carboplatin should be combined with repeated selected intra-arterial Bevacizumab plus Carboplatin to improve progression free and overall survival. The investigators expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to the investigators patients in the near future.
NCT03192215
Objectives * Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. * Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
NCT03975387
Study ASTX295-01 is a first in human Phase 1/2 open-label study of the safety, pharmacokinetics, and preliminary activity of ASTX295 in participants with wild-type TP53 advanced solid tumors. Phase 1 is a dose escalation and dose expansion study design. Sponsor made the strategic decision to not pursue the Phase 2 part of the study.
NCT01083966
A recent study by Plotkin et al. showed that bevacizumab (Avastin) treatment was followed by clinically meaningful hearing improvement, tumor-volume reduction, or both in some, but not all, patients with Vestibular Schwannoma (VS) who were at risk for complete hearing loss or brain-stem compression from growing VS. Because of the promising results in preliminary studies of Bevacizumab and because of significant experience with the safety of the dosages proposed in this study, this study will offer a safe treatment for patients with VS. Therefore, this phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS.
NCT04222309
This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients. All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
NCT02861898
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol). This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.
NCT03213002
The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.
NCT02633943
This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.
NCT05130788
The study team will develop and assess the feasibility and acceptability of a WeChat-based peer-group mobile messaging smoking cessation intervention targeting Chinese immigrant smokers in New York City (NYC). For Aim 1, the study team will develop a message library for the WeChat Quit Coach smoking cessation program and conduct in-depth interviews with 20 Chinese immigrant smokers in person to assess content relevance. For Aim 2, a two-arm, open-labeled, pilot randomized controlled trial (RCT) will be conducted to test the feasibility and acceptability of the WeChat Quit Coach intervention among 60 Chinese immigrant smokers. Participants will be randomized to intervention (n=40) or control group (n=20). Participants in the intervention group will receive a 6-week WeChat Quit Coach intervention through WeChat private group. Participants in the control group will receive a leaflet with information about existing smoking cessation programs that focus on Chinese American smokers. All the 60 participants will be offered a 4-week supple of nicotine replacement therapy (NRT) patches and/or lozenges. Participants will complete a baseline in-person survey at enrollment, a 6-week follow-up phone survey immediately after the intervention, and a 6-month follow-up phone survey. Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7-day at 6-week and 6-month follow-up surveys. Post-test in-depth interviews will be conducted with at least 20 participants in person from the intervention group at 6-week follow-up to obtain more information about the usability and perceptions about the WeChat Quit Coach program. For Aim 3, the investigators will conduct an open-labeled, 3-arm pilot RCT to test the preliminary effectiveness of the WeChat Quit Coach intervention with 90 Chinese immigrant smokers. Participants will be randomized to one of the three groups, including a 6-week intervention group A (IA; n = 30), a 12-week intervention group B (IB; n = 30), and a control group (n = 30). Participants in the intervention groups will either receive a 6-week (IA) or 12-week (IB) WeChat Quit Coach intervention through WeChat private groups. Participants in the control group will receive a leaflet with information of existing smoking cessation programs targeting Chinese American smokers. All 90 participants will be offered a 4-week free supply of NRT patches and/or lozenges. Participants will complete a baseline phone survey at enrollment, 12-week and 6-month follow-up phone surveys. A remote biochemical validation (saliva cotinine test) will be conducted at 12-week and 6-month follow-up to confirm smoking abstinence among those who self-report no smoking in the past 7 days. Post-test in-depth phone interviews will be conducted with up to 30 intervention participants to obtain more information about their perceptions and experience with the WeChat Quit Coach program.
NCT01604512
This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the tumor cells are actively growing. The investigators will do these two tests and see which one is better. Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Optional: Restriction Spectrum Imaging (RSI) Sequence RSI sequence is an advanced way of looking at your brain. The scan allows doctors to see how water is moving within brain tumors or within brain cells. The extra sequence takes additional 4-5 minutes in the scanner. The RSI sequence is optional. The patient will only be asked to participate if the doctor believes that it will be helpful. Off study: Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Patients will obtain a standard of care brain MRI scan about every 2-3 months. These MRI scans will be used to track disease progression.
NCT03068325
This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of Equine-Assisted Therapy for veterans with posttraumatic stress disorder (EAT-PTSD). While several well-studied, validated treatments for PTSD exist, some individuals find these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy widely used by organizations, such as PATH International Equine Services, that endorse its effectiveness for treating a variety of mental health issues. These claims have drawn criticism because the published research contains glaring methodological flaws, making it difficult to assess how effective these therapies actually are (Anestis et al., 2014). Equine-assisted therapies present a unique treatment modality that might effectively treat PTSD, particularly for individuals who have difficulty with other treatment modalities. In EAT, a psychotherapist and equine specialist work together to help the patients negotiate interactions with a horse using structured interventions or activities.
NCT04596891
The primary goal of this uncontrolled pilot trial is to examine feasibility, acceptability, safety, and preliminary efficacy of a new behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms of post-traumatic stress disorder (PTSD). Participants will be recruited among cardiac arrest survivors enrolled in the observational CANOE research study (CUIMC IRB# AAAR8497). Study participants will be interviewed about their symptoms and evaluated for baseline assessment before receiving eight weekly sessions of an acceptance and mindfulness-based exposure therapy (AMBET). Participants will be additionally evaluated at treatment mid-point (week 4), and at the end of treatment. The treatment and all assessments will be conducted remotely via Zoom. To assess whether patients' physical activity is improved over the course of treatment, participants will be provided with a wearable device (Fitbit wristband) to monitor their physical activity. The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for survivors of sudden cardiac arrest with elevated PTSD symptoms (2) examine its safety and feasibility in a small sample of 14 patients (3) investigate acceptability and feasibility of the assessments and measurements including physical activity.
NCT05968482
The goal of this clinical trial is to compare drug exposure from two different products (AMZ001 and Diclofenac Sodium 1% Gel) in healthy participants on Day 7 after repeated topical administrations for 7 days. Participants will receive, in a crossover design, three different treatments * AMZ001 Low dose * AMZ001 High dose * Diclofenac Sodium 1% Gel Safety and tolerability of AMZ001 will be also investigated.
NCT05977946
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vagus nerve (ABVN) or tAN, which targets the ABVN and the auriculotemporal nerve (ATN): 1. Group 1: Sham taVNS followed by active taVNS 2. Group 2: Sham tAN followed by active tAN Participants will receive 30 minutes of sham stimulation (taVNS or tAN), followed by active stimulation (taVNS or tAN). Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device.
NCT04758624
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
NCT05018650
The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters for aspiration thrombectomy in acute ischemic stroke patients.
NCT05355597
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
NCT05206357
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally. Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
NCT05432479
This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
