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NCT ID: NCT03260478 Completed - Clinical trials for Traumatic Brain Injury

HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

HEMOTION
Start date: August 31, 2017
Phase: N/A
Study type: Interventional

Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.

NCT ID: NCT03260322 Completed - Clinical trials for Advanced Solid Tumors

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Start date: September 8, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate [ORR], duration of response [DOR], persistence of response after discontinuation, and disease control rate [DCR]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia

NCT ID: NCT03259074 Completed - Clinical trials for Ankylosing Spondylitis

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

SURPASS
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

NCT ID: NCT03259035 Completed - Rectal Cancer Clinical Trials

NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

Start date: June 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.

NCT ID: NCT03258138 Completed - Quality of Life Clinical Trials

Feasibility and Implementation of a Healthy Lifestyles Program

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation) are often recommended to prevent or manage these conditions, but changing habits is difficult. Mental health can play a role in the ability to seek out and follow through on the changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely addressed, and access to mental health services is often limited. Furthermore, individuals are influenced by factors at the individual, interpersonal, community and policy levels (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and need to be addressed in order for individuals to make sustainable lifestyle changes. A new year-long person-centered healthy lifestyles program is proposed to address the "how to" gap in making lifestyle changes through a combination of individual and group sessions. The feasibility and implementation of this new program will be evaluated through a pilot study looking at the full healthy lifestyles program compared to a less intensive version of the program. The study's hypothesis is that the full program will be feasible, acceptable and more effective for helping participants move across stages of change and for meeting their goals than the less intensive program.

NCT ID: NCT03257579 Completed - Clinical trials for Medication Adherence

Myocardial Infarction Prescription Duration Adherence Study

MIPAD
Start date: September 5, 2017
Phase: N/A
Study type: Interventional

Quasi-experimental, controlled interrupted time series design, evaluating the impact of the intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education will be provided and St Joseph's Hospital (SJH) and Niagara Health Services (NHS) where education alone will be provided, with remaining Ontario cardiac sites as a concurrent control group.

NCT ID: NCT03257527 Completed - Well-being Clinical Trials

Enduring Happiness and Continued Self-Enhancement (ENHANCE) 2.0

Start date: April 10, 2017
Phase: N/A
Study type: Interventional

The study is designed to compare the efficacy of two programs intended to improve happiness and well-being among healthy, community adults between the ages of 25 and 75 years. Participants will complete either an in-person program (ENHANCE) or a mindfulness-based stress reduction (MBSR) self-help program over 3-months. The ENHANCE program will include 12-weekly sessions based on researched principles of happiness. Alternatively, the MBSR self-help guide will teach ways to replace stress-promoting habits. Participants will be asked to complete a series of measures at three points of the study: at the start of the study, the end of the study, and 3-months following the study.

NCT ID: NCT03257384 Completed - Clinical trials for Operating Room Efficiency

Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study

Start date: August 10, 2017
Phase:
Study type: Observational

The primary objective is to prospectively identify Operating Room (OR) time delays from the time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting the OR. This analysis will be used to identify root cause(s) leading to OR delays and define areas for improvement. The secondary objective is to identify any improvements in OR time delays and OR utilization following implementation of a standardized framework developed to increase OR efficiency.

NCT ID: NCT03257293 Completed - Bladder Cancer Clinical Trials

A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. However, there is limited research into reduction of patient discomfort throughout this procedure. The proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. It is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.

NCT ID: NCT03257267 Completed - Clinical trials for Squamous Cell Carcinoma (SCC)

Study of Cemiplimab in Adults With Cervical Cancer

Start date: September 5, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: - To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy - To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy - To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)