Clinical tria
Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use. COM (97) 369 final, 3 September 1997
... the trial with the possibility of rejecting it in specific sites if facilities are not appropriate; Whereas information both on the commencement and on the termination of a clinical tria[r] ...
26
Rationale and design of the randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder the EMC trial
... Subjects can be withdrawn their consent at their own request without given reasons at all time during the trial. This will be without disadvantages for the subject. However, the investigator should try to perform a final ...
17
Assessment of treatment response in chronic constipation clinical trials
... First, a targeted literature review was conducted to identify the symptoms reported by patients with CC in previous quali- tative and observational research, as well as the symptoms assessed in clinical trials of ...
8
Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013
... Abstract: A systematic review was performed to evaluate how the maximum recommended starting dose (MRSD) was determined in first-in-human (FIH) studies with monoclonal antibodies (mAbs). Factors associated with the ...
12
The JUPITER and AURORA clinical trials for rosuvastatin in special primary prevention populations: perspectives, outcomes, and consequences
... Abstract: Statins have emerged at the forefront of preventive cardiology and have significantly reduced cardiovascular events and mortality. Nonetheless, cardiovascular disease remains the leading cause of death in the ...
10
Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup Icu RENal, SIREN): Study protocol for a pre planned observational study
... randomized clinical trial on prophylactic proton pump inhibitor versus placebo in acutely admitted adult ICU patients at risk of gastrointestinal bleeding — we will compare the benefits and harms of prophylactic ...
7
Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke : study protocol for a pilot randomised controlled trial
... in clinical trials and the CONSORT guidelines, we will document all decisions regarding eligibility for entry, consent giving, inclusion, exclusion and ...the clinical stroke ...
12
Defining subpopulations of differential drug response to reveal novel target populations
... the clinical trial, there may be other potential indications for ...Future clinical trials testing MEK inhibitors in colorectal and pancreatic cancer could select patients possessing KRAS mutations to ...
12
Llovera Garcia, Gemma (2019): The choroid plexus in post-stroke neuroinflammation. Dissertation, LMU München: Medizinische Fakultät
... 2 clinical trial was initiated recently to test the effect of natalizu- mab in patients with acute ischemic stroke [ACTION (Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke) trial, Clinical- ...
99
The accuracy of surrogate decision makers: informed consent in hypothetical acute stroke scenarios
... When given a choice, the majority of patients and surrogates opted for standard treatments (tPA) over more experimental (scenario 2) or clinical trial (scenarios 3 and 4) alternatives. Possible explanations for ...
6
Microbicides Development Programme: Engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania
... of clinical care in this ...73 clinical trials of HIV prevention and treatment (n = 34); malaria pre- vention (n = 29); and tuberculosis treatment (n = 13), all conducted in sub-Saharan Africa, found that ...
12
The effect of quitting smoking on HDL-cholesterol - a review based on within-subject changes
... Table 2 summarizes details of the 45 studies, with fur- ther detail given in Additional file 1. Countries contrib- uting the most studies were USA (15) and Japan (7). Eleven studies were randomized clinical trials ...
12
Reporting of results of interventional studies by the information service of the National Institutes of Health
... of clinical trials with information about study sponsors and protocols makes clinical research more ...that clinical trials assessing pharmacologic treatments for serious or life-threatening diseases ...
8
A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies
... Background: Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded ...
9
Allogeneic umbilical cord-derived mesenchymal stem cell transplantation for treating chronic obstructive pulmonary disease: a pilot clinical study
... The first clinical trial was completed in the USA (NCT00683722) [50]. Sixty-two patients with moderate- to-severe COPD were randomized to intravenously re- ceive an infusion of either ex vivo cultured allogeneic ...
14
A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies
... Background: Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded ...
9
“A Short and Snappy Overview on the Attribution of Computers in Pharmacy” by Kinshuk Bhojwani, Anand Kushwaha, Saurabh Jain, Gunjan Kalyani, India.
... and clinical trials are the significant part which evaluates pharmacological profit along with the toxicological hazard coupled with the ...Oracle clinical V4i® from Oracle Corporation and Trial master® ...
5
An enhanced fuzzy linguistic term generation and representation for time series forecasting
... Then, the FLUBE is used for the Linguistic Term Generation and Representation Approach LinGRA so that the forecasts are represented with the linguistic terms, which are defined with Tria[r] ...
8
Subjective pitch and the generalization gradient.
... training tria ls with the standard 1000 mels tone, paired with shock; mm test tria l without shock, to the same pitch; and two other test tria ls to generali zation stim uli of 500 and 250 mels in ...
62
TRIA-MF protocol as an innovative tool in the comprehensive treatment and outcome evaluation of lower limb amputees before and after prosthesis use
... the TRIA-MF protocol is in place, capable of constituting in the next few years a real orientation to the economic dimension (budget and staff management) of the management of the amputee with the delineation of a ...
24