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Results 1321-1330 of 470744

Brain Stimulation for Severe Depression

Depression Severe

Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull. Over time, intracalvarial cortical stimulation is intermittently activated to modulate locally and distally connected brain regions. Because of the important role played by the dorsolateral prefrontal cortex in mood regulation, the goal of this study is to apply intracalvarial prefrontal cortical stimulation (IpCS) over the dorsolateral prefrontal cortex in severely treatment-resistant depressed (TRD) patients. Per the DSM-V and Centre for Medicare and Medicaid Services (CMS) nomenclatures, TRD patients are commonly defined as those whose treatment failed to produce response or remission after 2 or more attempts of sufficient duration and treatment dose. In the investigator's study, eligible TRD subjects will have a diagnosis of major depressive disorder with a suboptimal response to an adequate dose and duration of at least two different antidepressant treatment categories. These subjects will also have had exposure and transiently (non-durably) responded to non-invasive neurostimulation. The investigator anticipates that severely Treatment Resistant Depressed (TRD) Subjects with IpCS of the dorsolateral prefrontal cortex will show a significant decrease in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at four months post-implant when compared to baseline. The investigator will enroll up to 20 subjects with severe refractory depression in an open trial, followed for up to one year. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure.

Recruiting22 enrollment criteria

A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a...

Multiple Myeloma

The purpose of this study is to see if the quality of T cells used to create ide-cel (bb2121) affects how ide-cel prevents cancer from coming back in people with relapsed or refractory multiple myeloma (MM), and who have had a hematopoietic cell transplant.

Recruiting80 enrollment criteria

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Advanced CancerMetastatic Cancer

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

Recruiting10 enrollment criteria

A Trial of SHR0410 Injection in Postsurgical Pain Management

Postsurgical Pain

The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.

Recruiting20 enrollment criteria

Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory...

Overall Survival

This clinical trial is an investigator-initiated multicenter, open, prospective clinical study in order to explore the efficacy and safety of rituximab plus zanubrutinib and lenalidomide in relapsed and refractory diffuse large B cell lymphoma.

Recruiting14 enrollment criteria

Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute...

Acute Heart Failure

The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.

Recruiting38 enrollment criteria

Geriatric Hip Fractures Caregiver Programme

Geriatric Hip Fracture

Objective: To study whether fracture hip patients can be benefited from the empowerment program Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery. Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture. Design and subjects This is a prospective randomised controlled trial and subjects are fracture hip patients Instruments Ipads are needed to show the videos of the rehabilitation program Interventions The empowerment program consists of three main areas which directly correspond to the contents that the patients and caregivers expressed as most needed in interviews conducted by the investigators during hip fracture patients' follow up: Knowledge of the disease Confidence and skills in self-care management Support in the post-discharge period Main outcome measures Primary outcomes: Functional scores (Modified Barthel Index and EQ-5D-5L) at the first follow-up visit (3 months postop). Timed-up-and-go test at follow-up at 6 months and 1 year. Secondary outcome: Cumulative readmission rates at 1 month, 6 months, and 1 year The length of stay in the convalescent hospital Subsequent injury with fractures within 1 year Data analysis Chi-square test is used for categorical variables. For continuous variables, the normal distribution is determined by the Kolmogorov-Smirnov test. Independent t-test is used for comparing average values of normally distributed continuous variables, while the Wilcoxon rank sum test is used for comparing median values of abnormally distributed variables. Binary logistic regression is used to determine predictive factors for outcomes. Multivariate analysis is performed to verify independent predictive factors for outcomes. Expected results Fracture hip patients can be benefited from the empowerment program.

Recruiting9 enrollment criteria

EBA, Safety and Tolerability of Sanfetrinem Cilexetil

TuberculosisPulmonary

To evaluate the 2-week bactericidal activity, pharmacokinetics, safety and tolerability of sanfetrinem cilexetil in participants with rifampicin-susceptible pulmonary tuberculosis.

Recruiting41 enrollment criteria

Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

GlaucomaOcular Hypertension

The study purpose is to evaluate the safety of T4090.

Recruiting5 enrollment criteria

Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Mild Cognitive Impairment

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in individuals with Mild Cognitive Impairment (MCI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MCI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MCI. Through a small randomized clinical trial, the investigators found that individuals with MCI with documented cognitive impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign older individuals who meet criteria for a diagnosis of amnestic MCI to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery, (2) an assessment of global functioning examining the impact of the treatment on daily activities, and (3) functional neuroimaging. This design will allow the investigators to evaluate the efficacy of this particular memory retraining technique in an aMCI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow the investigators to look at changes in the brain.

Recruiting7 enrollment criteria
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