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NCT ID: NCT02597465 Withdrawn - Clinical trials for Advanced Biliary Tract Cancer

A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507

Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

An open label study to determine the efficacy and safety of SPARC1507

NCT ID: NCT02597309 Withdrawn - Diabetes, Obesity Clinical Trials

The Effect of add-on Canagliflozin in Patients With Type 2 Diabetes Treated With U-500 Insulin

I-Can
Start date: November 2015
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effect of adding a SGLT-2 inhibitor (namely Canagliflozin) on the dose of U-500 insulin required to achieve glycemic control in patients with type 2 diabetes. We hypothesize that adding Canagliflozin to patients treated with U-500 insulin may result in significant reduction in insulin dose due to improved insulin sensitivity and weight loss.

NCT ID: NCT02596178 Withdrawn - Clinical trials for Acute Respiratory Distress Syndrome

Titration of PEEP During Mechanical Ventilation in Patients With ARDS Using Electrical Impedance Tomography.

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Lung units that participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units that do not participate in gas exchange (i.e. the derecruited lung), which results in impaired gas exchange and induces an inflammatory cascade. The level of PEEP is often coupled to indices of oxygenation such as PaO2, PaO2 to FIO2 ratio, or oxygen index. Currently, two strategies are widely accepted and considered equivocal, one strategy using a lower PEEP level coupled to a certain oxygen requirement, the other using a higher PEEP level. The primary purpose of this study is to demonstrate the safety and efficacy of an electrical impedance tomography (EIT) PEEP titration protocol designed to recruit collapsed lung in children with ARDS and properly maintain lung volumes by setting an optimal PEEP level. A safety system has been developed using the ARDSnet FIO2/PEEP High (upper threshold limit) and Low (lower threshold limit) algorithm. Efficacy will be defined as an improvement in lung volume as assessed by electrical impedance tomography, lung compliance and by an improvement in markers of gas exchange. Safety will be defined as the incidence of barotrauma and hemodynamic consequences that occur during the protocol. Those results will be compared to incidences of barotrauma and hemodynamic compromise within the ARDS literature. Knowledge gained from this pilot will be instrumental in developing an EIT imagine guided protocol which will allow us to conduct future RCTs utilizing EIT technology

NCT ID: NCT02594358 Withdrawn - Amblyopia Clinical Trials

Caffeine in Amblyopia Study

CAS
Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial). Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety. Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family. Demonstrate recruitment potential of subjects to participate in a dietary intervention study.

NCT ID: NCT02593981 Withdrawn - Sleep Clinical Trials

Addressing Sleep Problems in Older Adults

Start date: March 2018
Phase: N/A
Study type: Interventional

As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals. The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.

NCT ID: NCT02591433 Withdrawn - Malignant Neoplasm Clinical Trials

JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer

Start date: August 2013
Phase: N/A
Study type: Interventional

This pilot clinical trial studies how well the "JeffQuit" group therapy program works in enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group therapy to provide psychological support and address the mental need for smoking, the habit or routine it creates, and the physical need for nicotine. It is not yet known how well the JeffQuit program will work in helping patients with a history of cancer to stop smoking.

NCT ID: NCT02589860 Withdrawn - Multiple Myeloma Clinical Trials

Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant

Start date: October 30, 2015
Phase:
Study type: Observational

This is a pilot study to explore and identify changes in molecular processes within the oral mucosa that are associated with the development of oral mucositis (OM) in patients treated with Melphalan who undergo autologous peripheral blood stem cell transplantation.

NCT ID: NCT02589509 Withdrawn - Clinical trials for Brain Injuries, Traumatic

Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

Start date: December 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.

NCT ID: NCT02589184 Withdrawn - Shoulder Pain Clinical Trials

Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises

Start date: October 2015
Phase: N/A
Study type: Interventional

Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.

NCT ID: NCT02588625 Withdrawn - Scleroderma Clinical Trials

A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Start date: February 2016
Phase: Phase 2
Study type: Interventional

This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020. The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using two different doses of BMS-986020.