protocol amendment

In clinical trials, a written description of one or more changes to, or formal clarifications of, the study protocol.

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The protocol amendment will expand patient eligibility and enable study investigators to administer AST-OPC1 to patients with injuries at one vertebral level higher than the trial's previous C-5 limitation, to the fourth cervical vertebra down, known as C-4, near the middle of the neck.

FDA approves enrollment of C-4 SCI patients in study

To address this challenge, we are implementing a protocol amendment for the ICT-107 trial that will modify some elements of how patients qualify for the trial, which is designed to accelerate the pace and efficiency of randomization.

United States : ImmunoCellular Therapeutics announces third quarter 2016 financial results and provides research and development update

Finally, during its Presidency, Athens hopes to be able to conclude the ratification process for the Kyoto Protocol amendment (Kyoto II).

CLIMATE CHANGE : RACE AGAINST TIME FOR ATHENS

Data recorded for each protocol submission included whether this was a first application or a protocol amendment, the sponsor of the trial, the principal investigator (PI), phase of trial (I, II, III or IV), and the year and month of submission.

Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa

There was protocol amendment to include younger patients (50 to 54years of age) or those with less recent strokes (within 90 to 120 days before randomization) if they also had at least two additional vascular risk factors.

What is better antiplatelet agent to prevent recurrent stroke?

Based on these favorable data, two actions are anticipated: (1) expansion of the initial cohort treated on the once-every-3-weeks dosing schedule from 25 to 40 patients; and (2) a protocol amendment to evaluate dosing on an alternate schedule (i.

Genta Updates Tesetaxel Clinical Trials Progress

Because of a protocol amendment during the study the end point was changed to cardiovascular hospitalization or all-cause mortality, which turned out not to be significantly different between the groups.

Panel backs Carvedilol's mortality benefit after acute MI. (Left Ventricular Dysfunction)

The upcoming meeting will include discussions on a Montreal Protocol amendment to address emissions of hydrofluorocarbons, potent greenhouse gases that are replacing ozone-depleting substances and are rapidly becoming a major contributor to global climate change.

United States : Statement by NSC Spokesperson Ned Price on the U.S. Delegation for the Meeting of the Parties to the Montreal Protocol

The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longer-term safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.

Promising results from follow-up of patients in critical limb ischemia feasibility study

The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longerterm safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.

Promising results from follow-up of patients in CLI feasibility study

The regulation will transpose the measures outlined by the Montreal Protocol amendment to the European Union and, even other countries.