Search for 'trials' - Neurosonology.net

Search in texts for 'trials' - Neurosonology.net'

Download page (1)

Also try: clinical trials,

151 results of 23 texts with exact phrase : 'trials'.

1. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 1, 2005, No. 2 , , ,

Carotid artery angioplasty with stenting is the second choice and is currently being used on selected patients who are at high risk for surgery and in controlled clinical trials.
The standard surgical treatment, carotid endarterectomy, has been widely used. Carotid artery angioplasty with stenting is the second choice and is currently being used on selected patients who are at high risk for surgery and in controlled clinical trials.
read the entire text >>

Over the years it evolved and became a routine surgical treatment for carotid stenosis although no adequate clinical trials confirmed its benefits.
In 1954 the first endarterectomy has been performed in a patient with symptomatic carotid artery stenosis. Over the years it evolved and became a routine surgical treatment for carotid stenosis although no adequate clinical trials confirmed its benefits. In 1998, two large randomized controlled trials of endarterectomy versus medical treatment published their final results. Although their design was similar, differences in inclusion and exclusion criteria, methods of determining degree of stenosis and definitions of outcome events existed. The Veterans Affairs Trial was the third trial and was stopped when initial results of the two large trials were published in 1991.
read the entire text >>

In 1998, two large randomized controlled trials of endarterectomy versus medical treatment published their final results.
In 1954 the first endarterectomy has been performed in a patient with symptomatic carotid artery stenosis. Over the years it evolved and became a routine surgical treatment for carotid stenosis although no adequate clinical trials confirmed its benefits. In 1998, two large randomized controlled trials of endarterectomy versus medical treatment published their final results. Although their design was similar, differences in inclusion and exclusion criteria, methods of determining degree of stenosis and definitions of outcome events existed. The Veterans Affairs Trial was the third trial and was stopped when initial results of the two large trials were published in 1991.
read the entire text >>

The Veterans Affairs Trial was the third trial and was stopped when initial results of the two large trials were published in 1991.
In 1954 the first endarterectomy has been performed in a patient with symptomatic carotid artery stenosis. Over the years it evolved and became a routine surgical treatment for carotid stenosis although no adequate clinical trials confirmed its benefits. In 1998, two large randomized controlled trials of endarterectomy versus medical treatment published their final results. Although their design was similar, differences in inclusion and exclusion criteria, methods of determining degree of stenosis and definitions of outcome events existed. The Veterans Affairs Trial was the third trial and was stopped when initial results of the two large trials were published in 1991.
read the entire text >>

Final results of both trials, European Carotid Surgery Trial (ECST) and North American
Final results of both trials, European Carotid Surgery Trial (ECST) and North American
read the entire text >>

In both trials no significant benefit of endarterectomy has been showed for patients with symptomatic carotid stenosis of less then
For patients with moderate symptomatic stenosis (50 to 69 percent), NASCET reported greater benefit of endarterectomy compared with medically treated patients, whereas ECST showed no significant benefit. NASCET showed that 15 patients with 50 to 69% stenosis would have to be treated to prevent one stroke within five years. In both trials no significant benefit of endarterectomy has been showed for patients with symptomatic carotid stenosis of less then
read the entire text >>

Trials
Trials
read the entire text >>

To better define the indications for CAS versus CEA several randomized prospective trials have been designed.
To better define the indications for CAS versus CEA several randomized prospective trials have been designed. Carotid and Vertebral Artery Transluminal Angioplasti Study (CAVATAS) showed no difference in major outcome events between endovascular treatment and carotid endarterectomy, but 30-day death and stroke rate of carotid surgery was higher than desirable – 10% versus 9.9% of CEA [12]. This study also reported that high grade carotid restenosis was more frequent one year after CAS then after carotid surgery. In SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endearterectomy) study, 334 patients were included (96 symptomatic and 219 asymptomatic) [13]. This trial suggested that stenting with protection is not inferior and may be superior to CEA in terms of a combined end point including stroke, myocardial infarction and death.
read the entire text >>

In Europe, three ongoing trials, SPACE (Stent protected Angioplasty versus Carotid Endarterectomy), EVA-3S and ICSS (International Carotid Stenting Study-CAVATAS-2), are recruiting symptomatic patients for randomization between CEA and CAS.
In North America, the CREST (Carotid Revascularisation Endarterectomy versus Stent Trial) protocol has been initiated. Its randomization goal is 1200 to 1600 symptomatic patients. In Europe, three ongoing trials, SPACE (Stent protected Angioplasty versus Carotid Endarterectomy), EVA-3S and ICSS (International Carotid Stenting Study-CAVATAS-2), are recruiting symptomatic patients for randomization between CEA and CAS.
read the entire text >>

Although several trials showed that carotid artery is as safe and effective as CEA, its use
Although several trials showed that carotid artery is as safe and effective as CEA, its use
read the entire text >>

should still be limited to controlled trials and ethic committees approved case series.
should still be limited to controlled trials and ethic committees approved case series.
read the entire text >>

2. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 2, 2006, No. 2 , , ,

Association and outcome with early stroke treatment: polled analysis of ATLANTIS, ECASS and NINDS rt-PA stroke trials.
Hacke W, Donnan G, Fieschi et al. Association and outcome with early stroke treatment: polled analysis of ATLANTIS, ECASS and NINDS rt-PA stroke trials.
read the entire text >>

3. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 3, 2007, No. 1 , , ,

However, until now the clinical trials, using the available neuroprotective drugs, are disappointing, although these agents have been found to reduce infarct size in animal stroke models.
channel modulators, inhibitors of NOmediated neurotoxicity and drugs, which modes of action are not quite clear. Some free-radical scavengers and antiinflammatory drugs could also exert neuroprotective action. However, until now the clinical trials, using the available neuroprotective drugs, are disappointing, although these agents have been found to reduce infarct size in animal stroke models. Combinations of neuroprotective drugs targeted at different stages of the ischemic cascade may be more useful. It has been suggested that the blockade of the angiotensin-renin system may protect the brain aganst ischemia. Statins also exhibit neuroprotective effects. Probably, transplanted stem cells may possess neuroprotective properties. It seems, the modification of the acute gene expression, induced by cerebral ischemia, and the apoptotic gene program could become promising treatment approach.
read the entire text >>

Cerebroprotection mediated by angiotensin II: a hypothesis supported by recent randomized clinical trials.
Fournier A, Messerli FH, Achard JM, Fernandez L. Cerebroprotection mediated by angiotensin II: a hypothesis supported by recent randomized clinical trials.
read the entire text >>

Lessons from neuroprotective stroke trials and new therapeutic directions.
Gladstone DJ, Black SE, Hakim AM. Toward wisdom from failure. Lessons from neuroprotective stroke trials and new therapeutic directions.
read the entire text >>

4. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 3, 2007, No. 2 , , ,

Choice of endpoints in antiplatelet trials: which outcomes are most relevant to strokepatients?
Albers GW. Choice of endpoints in antiplatelet trials: which outcomes are most relevant to strokepatients?
read the entire text >>

Design of clinical trials to test the homocysteine hypothesis of vascular disease.
Clarke R, Collins R. Can dietary supplements with folic acid or vitamin B6 reduce cardiovascular risk? Design of clinical trials to test the homocysteine hypothesis of vascular disease.
read the entire text >>

5. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 4, 2008, No. 1 , , ,

L. Proposed new duplex classification for threshold stenoses used in various symptomatic and asymptomatic carotid endarterectomy trials.
L. Proposed new duplex classification for threshold stenoses used in various symptomatic and asymptomatic carotid endarterectomy trials.
read the entire text >>

Randomized Clinical Trials: Impact on Clinical Practice for Symptomatic and Asymptomatic Extracranial Carotid Occlusive Disease.
Hobson RW. II. Randomized Clinical Trials: Impact on Clinical Practice for Symptomatic and Asymptomatic Extracranial Carotid Occlusive Disease.
read the entire text >>

6. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 4, 2008, No. 2 , , ,

Collaborative overview of randomised trials of antiplatelet therapy, I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients.
Antiplatelet Trialists’ Collaboration. Collaborative overview of randomised trials of antiplatelet therapy, I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients.
read the entire text >>

Comparison and meta-analysis of randomized trials of endarterectomy for symptomatic carotid artery stenosis.
Goldstein LB, Hasselblad V, Matchar DB, McCrory DC. Comparison and meta-analysis of randomized trials of endarterectomy for symptomatic carotid artery stenosis.
read the entire text >>

Collaborative metaanalysis of randomized trials of antiplatelet therapy for prevention of deth, myocardial infarction, and stroke in high risk patients.
Antithrombotic Trialists Collaboration. Collaborative metaanalysis of randomized trials of antiplatelet therapy for prevention of deth, myocardial infarction, and stroke in high risk patients.
read the entire text >>

Collaborative overview of randomized trials of antiplatelet therapy.
Antiplatelet Trialists Collaboration. Collaborative overview of randomized trials of antiplatelet therapy.
read the entire text >>

A randomized, blinder, trials of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE).
CAPRIE Steering Committee. A randomized, blinder, trials of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE).
read the entire text >>

7. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 6, 2010, No. 1 , , ,

Despite the relationship between plasma Hcy and ischemic stroke, we should wait for the results of the ongoing trials to know if the reduction of Hcy levels with vitamin therapy is of clinical benefit.
Despite the relationship between plasma Hcy and ischemic stroke, we should wait for the results of the ongoing trials to know if the reduction of Hcy levels with vitamin therapy is of clinical benefit.
read the entire text >>

Several multicentral trials demonstrate the benefit from TL in AIS, more important of which are the NINDS, the ECASS I and II, and the ATLANTIS.
Several multicentral trials demonstrate the benefit from TL in AIS, more important of which are the NINDS, the ECASS I and II, and the ATLANTIS. The NINDS study demonstrated that TL with rt-PA used within three hours after stroke onset significantly improves outcome in patients with AIS [30, 64]. Even within 3-hour therapeutic window, earlier treatment leads to better results [30]. Odds ratios were 2.8 (95%
read the entire text >>

The Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) was a multicentre, multinational observational study which confirmed that rt-PA, compared to placebo, is as effective and safe in the routine clinical practice as it was reported by previous large randomised controlled trials [63, 65, 68].
The Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) was a multicentre, multinational observational study which confirmed that rt-PA, compared to placebo, is as effective and safe in the routine clinical practice as it was reported by previous large randomised controlled trials [63, 65, 68]. TL for selected patients presenting with AIS between 3 and 4.5 hours was currently also included in the European labelling [modified January 2009], on the bases of ECASS-III study results [31]. Eligible patients with AIS for the ECASS-III were between 18 and 80 years of age. An absolute improvement of 7.2% for the rt-PA group, with an adjusted OR of favourable outcome (mRS 0-1) of 1.42, 1.02-1.98. Mortality rates did not differ significantly (7.7% versus 8.4%) between the groups. Cerebral hemorrhage was not observed with increased risk after rt-PA application (2.4% vs 0.2%) [31].
read the entire text >>

trials showed that SUs are very helpful to prevent death (within 12 weeks) by 28% and death one year after stroke by 17% relative risk reduction) [63].
trials showed that SUs are very helpful to prevent death (within 12 weeks) by 28% and death one year after stroke by 17% relative risk reduction) [63]. It is important to continuously educate and train stroke specialists in order to guarantee safe and efficient use of TL [9, 24, 32].
read the entire text >>

Evidence from randomized trials shows that SUs are more effective than general medical wards or geriatric wards or any other kind of
Evidence from randomized trials shows that SUs are more effective than general medical wards or geriatric wards or any other kind of
read the entire text >>

ATLANTIS Trials Investigators, ECASS Trials Investigators, NINDS rt-PA Study Group Investigators.
Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP, Brott T, Frankel M, Grotta JC, Haley EC Jr, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S. ATLANTIS Trials Investigators, ECASS Trials Investigators, NINDS rt-PA Study Group Investigators. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
read the entire text >>

Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP, Brott T, Frankel M, Grotta JC, Haley EC Jr, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S. ATLANTIS Trials Investigators, ECASS Trials Investigators, NINDS rt-PA Study Group Investigators. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
read the entire text >>

Endovascular Approaches to Acute Stroke, Part 2: A Comprehensive Review of Studies and Trials.
Nogueira RG, Yoo AJ, Buonanno FS, Hirsch JA. Endovascular Approaches to Acute Stroke, Part 2: A Comprehensive Review of Studies and Trials.
read the entire text >>

Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials; Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST).
Wahlgren N, Ahmed A, Eriksson N, Aichner F, Bluhmki E, Dávalos A, Erilä T, Ford GA, Grond M, Hacke W, Hennerici M, Kaste M, Köhrmann M, Larrue V, Lees KR, Machnig T, Roine RO, Toni D, Vanhooren G, for the SITSMOST investigators. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials; Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST).
read the entire text >>

8. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 7, 2011, No. 1 , , ,

Neuropsychological assessment revealed moderate dementia: MMSE: 15/30, BNT short version: 10/15; 10 words list recall (3 trials): 0/10, 2/10, 4/10; constructional praxis: 8/11; 10 word delayed recall: 1/10, with 2 intrusions; word recognition: not applicable (patient unable to understand task); literal verbal fluency for 1 min (letter М): 0; The four instrumental activities of daily living score (4-IADL): 4/4 points, marked impairment.
Clinical examination was normal. Neurological examination showed no focal signs. Neuropsychological assessment revealed moderate dementia: MMSE: 15/30, BNT short version: 10/15; 10 words list recall (3 trials): 0/10, 2/10, 4/10; constructional praxis: 8/11; 10 word delayed recall: 1/10, with 2 intrusions; word recognition: not applicable (patient unable to understand task); literal verbal fluency for 1 min (letter М): 0; The four instrumental activities of daily living score (4-IADL): 4/4 points, marked impairment. CERAD depression scale: 0 points, no depression. Brain MRI (fig. 1А) demonstrated cortical atrophy which was prominent in the left temporal lobe. PET/СТ with FDG (fig. 1B) provided evidence for temporal and parietal hypometabolism, more pronounced on the left, suggestive of Alzheimer’s disease.
read the entire text >>

Neuropsychological assessment revealed cognitive impairment without dementia: MMSE: 26/30, BNT short version: 14/15; 10 words list recall (3 trials): 4/10, 6/10, 6/10; constructional praxis: 11/11; 10 word delayed recall: 3/10, without intrusions; word recognition: 2 errors; literal verbal fluency for 1 min (letter М): 11; The four instrumental activities of daily living score (4-IADL): 0/4 points, no impairment. CERAD
Clinical examination was normal. Neurological examination showed no focal signs. Neuropsychological assessment revealed cognitive impairment without dementia: MMSE: 26/30, BNT short version: 14/15; 10 words list recall (3 trials): 4/10, 6/10, 6/10; constructional praxis: 11/11; 10 word delayed recall: 3/10, without intrusions; word recognition: 2 errors; literal verbal fluency for 1 min (letter М): 11; The four instrumental activities of daily living score (4-IADL): 0/4 points, no impairment. CERAD
read the entire text >>

duplex sonography for the assessment of intracranial arteries in clinical trials on acute stroke.
duplex sonography for the assessment of intracranial arteries in clinical trials on acute stroke.
read the entire text >>

The Consensus includes recommendations based on results of multicenter randomized clinical trials or meta-analysis (level of evidence A), single-center or non-randomized studies (level of evidence B) and expert advice or therapeutic standards (level of evidence C).
The consensus regulates noninvasive ultrasound diagnosis of carotid pathology and principles of behavior depending on its location, type, severity and functional characteristics. It serves as a practical guide for early diagnosis, adequate prevention, choosing the right therapeutic approach and long-term monitoring of threatened stroke risk population. Its application by different professionals contribute for high quality diagnostic, therapeutic and preventive health services in all units of outpatient and hospital care that are consistent with the level of competence of the hospital and the individual characteristics of the vascular pathology. The Consensus includes recommendations based on results of multicenter randomized clinical trials or meta-analysis (level of evidence A), single-center or non-randomized studies (level of evidence B) and expert advice or therapeutic standards (level of evidence C). Therapeutic and procedural recommendations are graded as required (class I), recommended (Class
read the entire text >>

9. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 7, 2011, No. 2 , , ,

Two large, phase 3 trials – TRANSFORMS and FREEDOMS demonstrated that fingolimod improved the clinical outcome for MS patients – reduced the annualized relapse rate, decreased the risk of confirmed disability progression and reduced the number and volume of brain lesions on MRI images.
(fingolimod), is the first oral drug licensed by the European Medicines Agency as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (MS). Fingolimod mediates its therapeutic effects through the immune system and directly on the central nervous system (CNS). Fingolimod reduces the recirculation of auto-reactive central memory Tcells and their infiltration in the CNS, where they would cause neurodegeneration. Peripheral lymphocyte count reduction is reversible and reflects the reversible retention of circulating lymphocytes in lymph nodes, but not their depletion. Two large, phase 3 trials – TRANSFORMS and FREEDOMS demonstrated that fingolimod improved the clinical outcome for MS patients – reduced the annualized relapse rate, decreased the risk of confirmed disability progression and reduced the number and volume of brain lesions on MRI images.
read the entire text >>

The effectiveness and safety profile of the oral treatment with fingolimod are demonstrated in phase 2 trials and in two big phase 3 trials – TRANSFORMS и FREEDOMS, published in New England Journal of Medicine in 2010.
The effectiveness and safety profile of the oral treatment with fingolimod are demonstrated in phase 2 trials and in two big phase 3 trials – TRANSFORMS и FREEDOMS, published in New England Journal of Medicine in 2010.
read the entire text >>

10. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 8, 2012, No. 1 , , ,

Modern meta-analysis on 5 randomized controlled trials involving 149 patients confirmed the analgesic effect of rTMS, recognizing good analgesic effect of low frequency rTMS in more therapeutic sessions.
The therapeutic effect of rTMS on primary motor cortex in the treatment of chronic neuropathic pain has been well studied. In small groups of patients treated for unresponsive neuropathic pain of different origin, including thalamic, after infarction and trigeminal neuralgia, a significant pain reduction after high-frequency10 Hz rTMS was found [31, 32]. In another study involving 28 patients with unresponsive unilateral neuropathic pain, a lasting pain relief 14 days after high-frequency 20 Hz rTMS was achieved [25]. Modern meta-analysis on 5 randomized controlled trials involving 149 patients confirmed the analgesic effect of rTMS, recognizing good analgesic effect of low frequency rTMS in more therapeutic sessions. The therapeutic effect is better on neuropathic pain with central than with peripheral origin [41].
read the entire text >>

Modern meta-analysis including 10 randomized controlled trials on 275 patients found positive effects of high frequency rTMS on motor symptoms in Parkinson's disease.
Clinical studies have shown statistically significant relief of bradykinesia and rigidity in high-frequency rTMS of primary motor cortex. These effects are short – only a few minutes after stimulation. The improvement in motor symptoms is explained by the release of endogenous dopamine in the ipsilateral striatum during stimulation [31]. More significant and lasting results are achieved after repeated stimulation. A double-blind, placebo-controlled study using eight rTMS sessions over a period of 4 weeks found a significant therapeutic effect on motor symptoms with duration of 1 month after the stimulation [34]. Modern meta-analysis including 10 randomized controlled trials on 275 patients found positive effects of high frequency rTMS on motor symptoms in Parkinson's disease. It is concluded that high-frequency rTMS is a promising method of treatment of motor impairments in this disease [32]. There are substantial differences between the rTMS protocols, selection of patients, duration and stage of disease in different studies. It is necessary to specify the optimal simulation parameters, the effects of rTMS on different disease stages, gait, cognition and memory.
read the entire text >>

The results from the application of low frequency rTMS in clinical conditions range from optimistic (reduction in seizure frequency by 36.2%) in uncontrolled studies to moderate and not very reliable in controlled randomized trials [2, 27].
Low frequency rTMS (≤ 1 Hz) decreases cortical excitability, while higher frequencies (> 5 Hz) increase it. In experimental conditions, low frequency rTMS (0.5 Hz) reduces the incidence of epileptic status and prolongs the latency of pentilentetrazol-induced seizures in rats. The results from the application of low frequency rTMS in clinical conditions range from optimistic (reduction in seizure frequency by 36.2%) in uncontrolled studies to moderate and not very reliable in controlled randomized trials [2, 27]. In a controlled blind study on 24 patients with focal epilepsy (temporal and extratemporal) and a coil located on the epileptogenic focus, a statistically significant change in relapse frequency was not found. A better effect was observed in neocortical than in mesiotemporal focuses [50]. A randomized, controlled clinical trial with simulated rTMS found a statistically significant reduction in EEG epileptiform activity and improvement in some aspects of cognitive activity lasting about 2 months after stimulation. All patients had cortical defects on brain convexity [27]. The response of surface and neocortical temporal foci correlates with the modern capabilities of TMS – the intensity of the induced electric field decreases rapidly in depth.
read the entire text >>

Effect of transcranial magnetic stimulation on Parkinson motor function-systematic review of controlled clinical trials.
Elahi B, Elahi B, and Chen, R. Effect of transcranial magnetic stimulation on Parkinson motor function-systematic review of controlled clinical trials.
read the entire text >>

Clinical trials of animal models suggest that only a small number (5% to 10%) of surviving axons are needed to support functional recovery.
Clinical trials of animal models suggest that only a small number (5% to 10%) of surviving axons are needed to support functional recovery. Recovery depends on the location, severity and type of the spinal cord injury, genetic possibilities for brain reorganization, adequacy of provided intensive care and neuroprotection, degree of spinal cord regeneration and possibilities of cell transplantation. Gray matter hypoperfusion and axonal demyelization areas are influenced [16].
read the entire text >>

11. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 2, 2012, No. 2 , , ,

clinical trials, neuroprotection,
clinical trials, neuroprotection,
read the entire text >>

The positive effect of mild hypothermia for increasing survival of patients after cardiac arrest and newborns with birth asphyxia for lowering the risk of brain damage was proved in controlled clinical trials and meta-analyses [21, 22].
The first article which focused on the effect of hypothermia in patients after severe head injuries was published in 1945. The first medical application of hypothermia was in 1950s. The method was used in intracranial aneurysm surgery for reaching of bloodless operational field. The early investigations were mostly focused on deep hypothermia leading to serious adverse events which limited its wide application. The neuroprotective effect of mild hypothermia was demonstrated in animal studies and in humans with brain ischemia and traumatic brain injuries. The positive effect of mild hypothermia for increasing survival of patients after cardiac arrest and newborns with birth asphyxia for lowering the risk of brain damage was proved in controlled clinical trials and meta-analyses [21, 22].
read the entire text >>

Data from randomized controlled trials (CoolCap, NICHD, TOBY) and meta-analyses prove the benefits of hypothermia for survival of infants without neurologic deficit for 18 months and reduction of brain development impairment.
Hypothermic therapy for neonatal encephalopathy is proven to reduce brain damages and increase survival of newborns with birth asphyxia [10, 23]. Therapeutic hypothermia decreases brain tissue injury in infants with hypoxic–ischemic encephalopathy. Data from randomized controlled trials (CoolCap, NICHD, TOBY) and meta-analyses prove the benefits of hypothermia for survival of infants without neurologic deficit for 18 months and reduction of brain development impairment. The objective of another trial – ICE determines the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complex hypothermia equipment. The study main conclusion is that the whole-body hypothermia is effective and appears to be safe when started within 6 hours after birth at hospital for term or near-term newborns with hypoxic-ischemic encephalopathy [12]. Additional evidences for persistence of ben-
read the entire text >>

Clinical trials in patients with severe closed head injury demonstrate the benefits of moderateTH.
There is a correlation related to body temperature of patients with ischemic stroke or brain trauma, measured at admission to the Intensive Care Unit (ICU) – patients with normal body temperature after the incident have a better prognosis than the others with febrility regardles the time of occurrence. The body temperature at admission is considered to be an independent predictor of the short-term outcome and long-term mortality after stroke [9, 13]. Many studies show that elevated temperature is associated with a worse outcome in patients with acute ischemic stroke [9]. Clinical trials in patients with severe closed head injury demonstrate the benefits of moderateTH. Hypothermic therapy in early stages after the incident when body temperature is kept low for a longer period could be a long-lasting neuroprotective measure but the hypothesis should be proved in further controlled clinical trials [9, 13].
read the entire text >>

Hypothermic therapy in early stages after the incident when body temperature is kept low for a longer period could be a long-lasting neuroprotective measure but the hypothesis should be proved in further controlled clinical trials [9, 13].
There is a correlation related to body temperature of patients with ischemic stroke or brain trauma, measured at admission to the Intensive Care Unit (ICU) – patients with normal body temperature after the incident have a better prognosis than the others with febrility regardles the time of occurrence. The body temperature at admission is considered to be an independent predictor of the short-term outcome and long-term mortality after stroke [9, 13]. Many studies show that elevated temperature is associated with a worse outcome in patients with acute ischemic stroke [9]. Clinical trials in patients with severe closed head injury demonstrate the benefits of moderateTH. Hypothermic therapy in early stages after the incident when body temperature is kept low for a longer period could be a long-lasting neuroprotective measure but the hypothesis should be proved in further controlled clinical trials [9, 13].
read the entire text >>

Further controlled clinical trials are needed for collection of sufficient data about the place of TH in a wide spectrum of medical conditions.
The use of TH is included in the guidelines for management of patients after cardiac arrest and newborns with neonatal encephalopathy after birth asphyxia. Although being used for ages the method is not been well investigated for other indications yet. Further controlled clinical trials are needed for collection of sufficient data about the place of TH in a wide spectrum of medical conditions.
read the entire text >>

Systematic review of randomized controlled trials of therapeutic hypothermia as a neuroprotectant in post cardiac arrest patients.
Cheung K, Green R, Magee K. Systematic review of randomized controlled trials of therapeutic hypothermia as a neuroprotectant in post cardiac arrest patients.
read the entire text >>

Therapeutic hypothermia for acute ischemic stroke: ready to start large randomized trials?
Van der Worp H, Macleod R, Kollmar R. Therapeutic hypothermia for acute ischemic stroke: ready to start large randomized trials?
read the entire text >>

Several parallel controlled clinical trials investigate the effect of moderate TH in acute ischemic
Several parallel controlled clinical trials investigate the effect of moderate TH in acute ischemic
read the entire text >>

Body surface cooling or endovascular cooling methods are used as well as both methods are used at some of the trials.
stroke [13, 23, 25]. A half of them are non-randomized and two are double blind. Body surface cooling or endovascular cooling methods are used as well as both methods are used at some of the trials. The specified temperature for hypothermia is 33°C and for normothermia – 36.5°C. When comparing the results, most of them report about mild and temporary improvement of patients after acute ischemic stroke although there is no significant change in the focal neurologic symptoms (standard scales for assessment of neurologic deficit were used after 7–30 days or
read the entire text >>

The clinical trials on that topic are still insufficient.
3 months after the application of hypothermia). Only one trial demonstrates an improvement according to NIHSS. The clinical trials on that topic are still insufficient.
read the entire text >>

Its routine application in neurology practice would be based on the results from the present and future international multicenter clinical trials.
The reviewed data demonstrates that the therapeutic hypothermia is a promising method for neuroprotection and treatment of acute ischemic stroke which could be applied alone or in combination with other treatment methods. Its routine application in neurology practice would be based on the results from the present and future international multicenter clinical trials.
read the entire text >>

Therapeutic hypothermia for acute ischemic stroke: ready to start large randomized trials?
van der Worp H, Macleod R, Kollmar R. Therapeutic hypothermia for acute ischemic stroke: ready to start large randomized trials?
read the entire text >>

Clinical Stroke Trials and Neurosonology Neurorehabilitation Experimental Neurophysiology
Clinical Stroke Trials and Neurosonology Neurorehabilitation Experimental Neurophysiology
read the entire text >>

12. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 9, 2013, No. 1 , , ,

Several clinical trials on angioplasty have started since, and numerous desperate MS patients seek relief from their incurable disease through questionable medical procedures.
ported a correlation of the clinical course of MS with specific patterns of venous obstructions [9]. Subsequently, they reported improvement in the Multiple Sclerosis Functional Composite (MSFC) in relapsing remitting MS and a reduction of Gadolinium enhancing lesions on brain MRI during a mean follow-up of 18 months in a small monocentric open angioplastic intervention study [66]. “CCSVI” and its presumed efficacious therapeutic approach termed “liberation treatment” caused enormous interest in the scientific community, amongst patient support groups and in the media. Several clinical trials on angioplasty have started since, and numerous desperate MS patients seek relief from their incurable disease through questionable medical procedures. However, in the meantime the number of publications that refute the “CCSVI” hypothesis has far exceeded that of its supporters. This review aims to analyse and critically comment on methodical aspects of “CCSVI” in the context of (patho-)physiological plausibility, which refers mainly to color-coded duplex ultrasonography (US), which is the only method according to Zamboni to define “CCSVI”.
read the entire text >>

13. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 9, 2013, No. 2 , , ,

Which Study Design is Appropriate for Sonothrombolysis Trials?
Which Study Design is Appropriate for Sonothrombolysis Trials? The ULTRAS Pilot Study.
read the entire text >>

Among different treatment schemes, sonothrombolysis has been used in in vitro tests, in preclinical trials and to a lesser extent in clinical trials, even though the exact underlying mechanism has not been fully clarified.
Rapid restoration of vascular flow is the primary goal of acute stroke treatment, while improvement in patient’s outcome is the ultimate benefit of such treatments. Among different treatment schemes, sonothrombolysis has been used in in vitro tests, in preclinical trials and to a lesser extent in clinical trials, even though the exact underlying mechanism has not been fully clarified.
read the entire text >>

WHICH STUDY DESIGN IS APPROPRIATE FOR SONOTHROMBOLYSIS TRIALS?
WHICH STUDY DESIGN IS APPROPRIATE FOR SONOTHROMBOLYSIS TRIALS? THE ULTRAS PILOT STUDY
read the entire text >>

Three important randomised controlled trials, the CARESS, the ACES and the CLAIR-trial have been performed.
only little is known about atrial fibrillation and MES. Three important randomised controlled trials, the CARESS, the ACES and the CLAIR-trial have been performed. They will also be reviewed, because they demonstrate the specific value of MD as surrogate endpoint for future strokes.
read the entire text >>

Prospective clinical trials are needed to demonstrate if imaging methods do indeed result in an improvement in defining unstable plaques and if they can predict patient outcomes, particularly in asymptomatic subjects.
It is at present undecided whether one imaging modality or a multimodality approach is most effective. Prospective clinical trials are needed to demonstrate if imaging methods do indeed result in an improvement in defining unstable plaques and if they can predict patient outcomes, particularly in asymptomatic subjects.
read the entire text >>

Traces obtained from fTCD (whose task consisted in description of a cartoon, with 30 trials, each lasting 38 sec) were processed by Average software that provided a lateralization index (LI) which, if positive, indicated a left hemisphere language lateralization.
CI (N=14; 9 female, mean age 6 years, range 4-13) were divided by age of implant in ‘early’ (ECI, 6 subjects, implant 30 months). CG included normal-hearing subjects matched for sex, age and hand preference. Traces obtained from fTCD (whose task consisted in description of a cartoon, with 30 trials, each lasting 38 sec) were processed by Average software that provided a lateralization index (LI) which, if positive, indicated a left hemisphere language lateralization.
read the entire text >>

14. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 10, 2014, No. 1 , , ,

Thrombolysis in very elderly people: controlled comparison of SITS International Stroke Thrombolysis Registry and Virtual International Stroke Trials Archive.
Mishra N, Ahmed N, Andersen G. Thrombolysis in very elderly people: controlled comparison of SITS International Stroke Thrombolysis Registry and Virtual International Stroke Trials Archive.
read the entire text >>

Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profle in randomized controlled trials: Safe lmplementation of Thrombolysis in Stroke-Monitoring Study (SlTS-MOST).
hrmann M, Larrue W, Lees K, Machnig T, Roine R, Toni D, Vanhooren G. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profle in randomized controlled trials: Safe lmplementation of Thrombolysis in Stroke-Monitoring Study (SlTS-MOST).
read the entire text >>

Сlinical trials in patients with malignant МСА infarction show that decompressive craniectomy is life-saving and can significantly reduce mortality [1, 13].
The clinical picture is characterized by changes in consciousness, progressive focal neurologic symptoms and brainstem dysfunction. Neuroimaging studies support the clinical picture. Extensive МСА infarction (more than 50% of its territory) with edema can be identified on СT scans in approximately 70% of the cases [19, 21]. Parenchymal hypodensity in greater than 50% of МСА territory is highly indicative for a progressive clinical course, leading to severe disability or death. lt's assumed that signs for extensive МСА infarction are: hyperdensity of the МСА, parenchymal hypodensity in greater than 1/3 of the МСА territory, hypodensity of basal ganglia. Сlinical trials in patients with malignant МСА infarction show that decompressive craniectomy is life-saving and can significantly reduce mortality [1, 13]. Diagnosis is based on clinical and СT/МRl changes. The presented clinical case shows the therapeutic possibilities of the decompressive craniectomy and raises questions about this procedure's timing and indications. lt's considered that the early treatment is linked with a better prognosis, although the optimal time window for performing surgery is still debated [5, 6, 8, 11].
read the entire text >>

Up to now no randomized, controlled trials have assessed the effectiveness of pyrexia control. [22].
А correlation is observed between the high levels of blood glucose after reanimationduetocardiacarrestandthe severity of the neurological deficiency. In a large randomized trial in patients admitted to a general intensive care unit the conventional glucose control (�10mmol/L) is compared with the intensive one (4,5-6.0 mmol/L). The 90-day mortality is higher in the group of patients with intensive glucose control [10]. Аccording to the recent guidelines for adult patients after ROSC the level of blood glucose shouldbekept�10mmol/L andtheintensive glucose control should be avoided due to the risk of hypoglycemia. Нyperthermia is common during the first 48 hours of IRS and associates with poor outcomes. Up to now no randomized, controlled trials have assessed the effectiveness of pyrexia control. [22].
read the entire text >>

lnformation obtained by new, prospective and controlled clinical trials and observations is expected as well.
analysis on a large-scale database since such has been established only in USA (NRCPR). lnformation obtained by new, prospective and controlled clinical trials and observations is expected as well.
read the entire text >>

15. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 10, 2014, No. 2 , , ,

Primary investigation areas: cerebral vascular disease, cerebral hemodynamics, neurosonology and syndrome of orthostatic intolerance / autonomic nervous system; Participated in several investigation projects with other national and international centres, on the described areas, besides coordinating some clinical trials; Organized 93 courses and meetings, some of them international; Held 289 lectures and participated in 276 in scientific presentations.
Coordinator of the cerebrovascular investigation of the Unit of Cardiovascular Investigation of FMUP (since 2007). Primary investigation areas: cerebral vascular disease, cerebral hemodynamics, neurosonology and syndrome of orthostatic intolerance / autonomic nervous system; Participated in several investigation projects with other national and international centres, on the described areas, besides coordinating some clinical trials; Organized 93 courses and meetings, some of them international; Held 289 lectures and participated in 276 in scientific presentations. She is author of 197 papers published as abstracts and 55 published as full-texts in national and international journals, 5 chapters of books and edited 4 scientific publications and has received 6 scientific awards. She collaborates with various national and international work groups, within both clinical and investigation projects.
read the entire text >>

Trials:
Trials:
read the entire text >>

involved as “investigator” in many trials, such as IST, SAINT-I, SPARCL, ECASS III, PROFESS, DIALOGUE; Referee for STROKE, Cerebrovasc Dis, J Neuroimaging, NEUROLOGICAL SCIENCE, Calcified Tissue Tnternational.
involved as “investigator” in many trials, such as IST, SAINT-I, SPARCL, ECASS III, PROFESS, DIALOGUE; Referee for STROKE, Cerebrovasc Dis, J Neuroimaging, NEUROLOGICAL SCIENCE, Calcified Tissue Tnternational.
read the entire text >>

Hart and colleagues performed a meta-analysis of clinical trials (n=6), showing that warfarin reduced the relative risk of stroke in 64% compared with the placebo, and that reduction in stroke risk is greater for secondary prevention [13].
Hart and colleagues performed a meta-analysis of clinical trials (n=6), showing that warfarin reduced the relative risk of stroke in 64% compared with the placebo, and that reduction in stroke risk is greater for secondary prevention [13].
read the entire text >>

related to a persuasive evidence of frequently being thromboembolic (Embolic strokes of Undetermined Source ESUS), have recently to planning randomised trials to test direct-acting oral anticoagulants for secondary prevention of these ESUS [14].
related to a persuasive evidence of frequently being thromboembolic (Embolic strokes of Undetermined Source ESUS), have recently to planning randomised trials to test direct-acting oral anticoagulants for secondary prevention of these ESUS [14].
read the entire text >>

At present, the current criteria for VaD such as the DSM-IV, select an heterogeneous group and may have biased findings in research studies and clinical trials.
Although relatively easy to define, VaD has proved difficult to diagnose because of the wide variability in mechanisms, brain changes, syndromes, and course. At present, the current criteria for VaD such as the DSM-IV, select an heterogeneous group and may have biased findings in research studies and clinical trials. In 1993, the NINDS-AIREN International Work Group [20] proposed diagnostic criteria for VaD focusing on the delineation of the clinical subtypes of VaD, consistent with the heterogeneity of dementia syndrome from CVD. Accordingly, the main subcategories of ischaemic VaD include multi-infarct dementia, strategic single-infarct dementia, and small-vessel disease with dementia.
read the entire text >>

Many studies dedicated to development of drug treatment for VaD suggested that subcortical VaD, caused by small vessel disease, represents a more homogeneous subtype for clinical trials [11].
Many studies dedicated to development of drug treatment for VaD suggested that subcortical VaD, caused by small vessel disease, represents a more homogeneous subtype for clinical trials [11]. However, there are some limitations in the current criteria for the diagnosis of subcortical VaD, such as the definition of the cognitive syndrome and the necessity of relationship between onset of dementia and CVD.
read the entire text >>

Research criteria for subcortical va scular dementia in clinical trials.
Erkinjuntti T, Inzitari D, Pantoni L, Wallin A, Scheltens P, Rockwood K, Roman GC, Chui H, Desmond DW. Research criteria for subcortical va scular dementia in clinical trials.
read the entire text >>

Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials.
Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials.
read the entire text >>

Roman GC, Tatemichi TK, Erkinjuntti T, Cummings JL, Masdeu JC, Garcia JH, Amaducci L, Orgogozo JM, Brun A, Hofman A, Moody DM, O'Brien MD, Yamaguchi T, Grafman G, Drayer BP, Bennett DA, Fisher M, Pajeau AK, Bell MA, DeCarli C, Culebras A, Korczyn AD, Bogousslavsky J, Hartmann A, Scheinberg P: Vascular dementia: diagnostic criteria for research studies (Report of the Erkinjuntti T, Inzitari D, Pantoni L, Wallin A, Scheltens P, Rockwood K, Roman GC, Chui H, Desmond DW: Research criteria for subcortical va scular dementia in clinical trials.
Roman GC, Tatemichi TK, Erkinjuntti T, Cummings JL, Masdeu JC, Garcia JH, Amaducci L, Orgogozo JM, Brun A, Hofman A, Moody DM, O'Brien MD, Yamaguchi T, Grafman G, Drayer BP, Bennett DA, Fisher M, Pajeau AK, Bell MA, DeCarli C, Culebras A, Korczyn AD, Bogousslavsky J, Hartmann A, Scheinberg P: Vascular dementia: diagnostic criteria for research studies (Report of the Erkinjuntti T, Inzitari D, Pantoni L, Wallin A, Scheltens P, Rockwood K, Roman GC, Chui H, Desmond DW: Research criteria for subcortical va scular dementia in clinical trials.
read the entire text >>

The most used traditional therapeutic approaches are founded by Bobath which has failed in clinical trials to be more effective in comparison with unspecific approaches.
The most used traditional therapeutic approaches are founded by Bobath which has failed in clinical trials to be more effective in comparison with unspecific approaches. Thus, the target agreements with patients in relation to ICF are improvement of physical fitness, balance and gait. Walking training improves walking capacity and self-care in different stages of stroke, but the training frequency should be high. However, the effects of training on death, dependence, and disability after stroke are unclear. There is evidence to incorporate cardiorespiratory training involving walking within post-stroke rehabilitation program to improve speed, tolerance, and independence during walking. For the treatment of pain coordination with physical and pharmacological therapies are recommended.
read the entire text >>

CIT has been shown to be effective in the recovery of arm and hand functions after stroke in multisite randomized clinical trials.
of learned nonuse in that the preference for the less affected arm is learned as a result of unsuccessful repeated attempts in using the affected arm. The constraint-induced therapy (CIT) protocol, which was proved in animal experimental settings, which forces the use of the affected limb by restraining the use of the less affected limb, has been specifically developed to reverse learned nonuse. CIT has been shown to be effective in the recovery of arm and hand functions after stroke in multisite randomized clinical trials. Other therapeutic strategies with circle training containing multiple functionalities are promising. The application of mirror is done to pretend the brain with a normalized illusion of motion of the paretic arm and hand. This supports the hypothesis of reconnecting brain areas.
read the entire text >>

gren T, Paltamaa J, Heinonen A Evidence for the effectiveness of walking training on walking and self-care after stroke: a systematic review and metaanalysis of randomized controlled trials.
gren T, Paltamaa J, Heinonen A Evidence for the effectiveness of walking training on walking and self-care after stroke: a systematic review and metaanalysis of randomized controlled trials.
read the entire text >>

Only few randomized controlled intervention trials have established that intensive practice with the affected hand and arm for 3 to 6 hours/day for 2 weeks can result in increased number of active TMS sites compared to less intensive treatment or no treatment [6].
It is well established in patients with stroke that MEPs from the lesioned hemisphere are smaller than those obtained from the non-lesioned hemisphere and smaller than those of age-matched healthy subjects [5]. In addition, an increase in the MEP amplitudes is accompanied by an improvement of clinical and functional scores. However, many of the earlier intervention studies concentrated on hand motor cortex. Only few randomized controlled intervention trials have established that intensive practice with the affected hand and arm for 3 to 6 hours/day for 2 weeks can result in increased number of active TMS sites compared to less intensive treatment or no treatment [6]. The enlarged motor representation in the lesioned hemisphere was shown to remain for up to 4 months in the follow-up period. In our previous clinical trial, the MEP amplitudes in the lesioned hemisphere increased after 2 weeks of intensive hand and arm exercise therapy [7]. Similar results were obtained e.g. by Koski et al. [8], who reported that MTs decreased after more training, whereas MEP amplitude and map size
read the entire text >>

A safety override button could be used to terminate trials with immediate effect if required.
Their arm was de-weighted according to individual need and task using a SaeboMAS® arm support (Saebo, Charlotte, USA). Electrodes were positioned on the anterior deltoid, triceps and an electrode array was used over the common extensor complex of the forearm. Joint angles of the shoulder, elbow and wrist were recorded using a Kinect® (Microsoft, Washington) and a PrimeSense (Apple Inc, California). Data from these sensors fed into the control algorithm hardware and software, which updated the ES control signals for each muscle group to provide enough ES to assist performance. The therapist used the operator monitor displaying the GO-SAIL graphical user interface to select appropriate tasks and monitor training. A safety override button could be used to terminate trials with immediate effect if required.
read the entire text >>

A meta analysis of randomized and non-randomized trials on ST [15] and a Cochrane Review of all the randomized studies published on ST
A meta analysis of randomized and non-randomized trials on ST [15] and a Cochrane Review of all the randomized studies published on ST
read the entire text >>

There are some ongoing trials, one no-profit Ital-
2), with no effect on mortality (Fig. 3). An increase of asymptomatic and symptomatic hemorrhages was mainly due to the concomitant use of microbubbles (Fig. 4) [16, 17, 18, 19, 20], further enhancing clot lysis and blood brain barrier (BBB) disruption. Nevertheless, other studies reported no effect of US on BBB and did not show any increase of apoptosis and markers of tissue damage outside the infarcted area [21]. The possible usefulness of microbubbles is a promising field for researchers and for drugs development. There are some ongoing trials, one no-profit Ital-
read the entire text >>

Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP,Brott T, Frankel M, Grotta JC, Haley EC Jr, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S, ATLANTIS Trials Investigators, ECASS Trials Investigators, NINDS rt-PA Study Group Investigators.
Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP,Brott T, Frankel M, Grotta JC, Haley EC Jr, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S, ATLANTIS Trials Investigators, ECASS Trials Investigators, NINDS rt-PA Study Group Investigators. Association of outcome with
read the entire text >>

early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
read the entire text >>

16. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 11, 2015, No. 1 , , ,

It is an initiative made by medical professionals to certify the quality in acute stroke treatment and secondary prevention and to accelerate clinical trials.
The register “Safe Implementation of Treatments in Stroke” (SITS) is a non-profit, research driven, independent international collaboration. It is an initiative made by medical professionals to certify the quality in acute stroke treatment and secondary prevention and to accelerate clinical trials.
read the entire text >>

Data of efficacy and safety from randomized controlled trials were based on observations in less than 1000 patients, although systematic statistical reviews indicated a statis
orrhagic complications and death could increase with the broad implementation of the treatment in European countries. Data of efficacy and safety from randomized controlled trials were based on observations in less than 1000 patients, although systematic statistical reviews indicated a statis
read the entire text >>

Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials; Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST).
hrmann M, Larrue V, Lees KR, Machnig T, Roine RO, Toni D, Vanhooren G. For the SITS-MOST investigators. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials; Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST).
read the entire text >>

17. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 11, 2015, No. 2 , , ,

Randomized controlled trials (RCT) comparing intravenous thrombolysis (IVT) with TE performed separately and with IVT plus TE were not available until 2013.
Randomized controlled trials (RCT) comparing intravenous thrombolysis (IVT) with TE performed separately and with IVT plus TE were not available until 2013. During the International Stroke Conference, Febrary 6–8, 2013, three RCT's – the IMS III, MR RESCUE and SYNTHESIS trials were presented and simultaneously published in the New England Journal of Medicine (NEJM). These trials, criticized
read the entire text >>

During the International Stroke Conference, Febrary 6–8, 2013, three RCT's – the IMS III, MR RESCUE and SYNTHESIS trials were presented and simultaneously published in the New England Journal of Medicine (NEJM).
Randomized controlled trials (RCT) comparing intravenous thrombolysis (IVT) with TE performed separately and with IVT plus TE were not available until 2013. During the International Stroke Conference, Febrary 6–8, 2013, three RCT's – the IMS III, MR RESCUE and SYNTHESIS trials were presented and simultaneously published in the New England Journal of Medicine (NEJM). These trials, criticized
read the entire text >>

These trials, criticized
Randomized controlled trials (RCT) comparing intravenous thrombolysis (IVT) with TE performed separately and with IVT plus TE were not available until 2013. During the International Stroke Conference, Febrary 6–8, 2013, three RCT's – the IMS III, MR RESCUE and SYNTHESIS trials were presented and simultaneously published in the New England Journal of Medicine (NEJM). These trials, criticized
read the entire text >>

The most important of these trials are SWIFT PRIME, ESCAPE and REVASCAT, all showing a clear and statistically significant superiority of TE – mostly plus IVT versus IVT alone.
During the next half year a number of further studies were presented and mostly simultaneously published in the NEJM. The most important of these trials are SWIFT PRIME, ESCAPE and REVASCAT, all showing a clear and statistically significant superiority of TE – mostly plus IVT versus IVT alone.
read the entire text >>

This technique is still applicable only in high risk patients and the use of the method in moderate risk patients is limited by the lack of clinical data and randomized trials.
Trans-catheter aortic valve implantation (TAVI) is a relatively new option for patients with severe aortic stenosis and high risk of an open surgery (multiple comorbidities, elderly patients). This technique is still applicable only in high risk patients and the use of the method in moderate risk patients is limited by the lack of clinical data and randomized trials.
read the entire text >>

The three major trials for evolucomab (PCSK9 inhibitor) show a mean of 57% lowering
The bio-absorbable stents are considered the third revolution in stent technology (after the development of the first bare metal stents and the first drug eluting stents). Long-term results of the ABSORB study showed that on the fifth year of follow-up of 30 patients with implanted Absorb BVS, no stent thrombosis, need for revascularization as a result of in-stent restenosis and death due to cardiovascular event were reported. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new opportunity for better lipid control in patients intolerable to statins or with poor control with the maximum tolerated statin dose. The three major trials for evolucomab (PCSK9 inhibitor) show a mean of 57% lowering
read the entire text >>

Most of the trials used intra-coronary delivery of bone marrow stem cells, following successful stenting of the infarct-related artery.
Cardiovascular diseases are a leading cause of morbidity and mortality worldwide. Despite advances in medical treatment and cath-based therapy for acute myocardial infarction (AMI) the mortality rate on the first year is 13% and the 5-year prognosis for patients to develop heart failure (HF) is 50%. Left ventricular systolic dysfunction after STEMI is a major determinant of prognosis and is associated with significant loss of cardiomyocytes. Cell transplantation is a new therapeutical approach in patients with HF after a myocardial infarction. Most of the trials used intra-coronary delivery of bone marrow stem cells, following successful stenting of the infarct-related artery. The improvement in the LVEF, reduction in size of scar tissue and reduction in cardiac volume were markers to assess the efficacy of cell therapy. Four main randomized controlled trials (RCTs) were published with positive findings (improved LVEF, improvement in regional contractility and reduction of the infarcted area). Three randomized controlled trials showed no changes in global LVEF and no changes in global or regional LV systolic function after BMSC infusion. There were no safety issues it the conducted trials. Possible reasons for the inconsistent findings are the variations in the number of delivered cells, timing of delivery after AMI and the differences in the cell isolation protocol.
read the entire text >>

Four main randomized controlled trials (RCTs) were published with positive findings (improved LVEF, improvement in regional contractility and reduction of the infarcted area).
Despite advances in medical treatment and cath-based therapy for acute myocardial infarction (AMI) the mortality rate on the first year is 13% and the 5-year prognosis for patients to develop heart failure (HF) is 50%. Left ventricular systolic dysfunction after STEMI is a major determinant of prognosis and is associated with significant loss of cardiomyocytes. Cell transplantation is a new therapeutical approach in patients with HF after a myocardial infarction. Most of the trials used intra-coronary delivery of bone marrow stem cells, following successful stenting of the infarct-related artery. The improvement in the LVEF, reduction in size of scar tissue and reduction in cardiac volume were markers to assess the efficacy of cell therapy. Four main randomized controlled trials (RCTs) were published with positive findings (improved LVEF, improvement in regional contractility and reduction of the infarcted area). Three randomized controlled trials showed no changes in global LVEF and no changes in global or regional LV systolic function after BMSC infusion. There were no safety issues it the conducted trials. Possible reasons for the inconsistent findings are the variations in the number of delivered cells, timing of delivery after AMI and the differences in the cell isolation protocol.
read the entire text >>

Three randomized controlled trials showed no changes in global LVEF and no changes in global or regional LV systolic function after BMSC infusion.
Left ventricular systolic dysfunction after STEMI is a major determinant of prognosis and is associated with significant loss of cardiomyocytes. Cell transplantation is a new therapeutical approach in patients with HF after a myocardial infarction. Most of the trials used intra-coronary delivery of bone marrow stem cells, following successful stenting of the infarct-related artery. The improvement in the LVEF, reduction in size of scar tissue and reduction in cardiac volume were markers to assess the efficacy of cell therapy. Four main randomized controlled trials (RCTs) were published with positive findings (improved LVEF, improvement in regional contractility and reduction of the infarcted area). Three randomized controlled trials showed no changes in global LVEF and no changes in global or regional LV systolic function after BMSC infusion. There were no safety issues it the conducted trials. Possible reasons for the inconsistent findings are the variations in the number of delivered cells, timing of delivery after AMI and the differences in the cell isolation protocol.
read the entire text >>

There were no safety issues it the conducted trials.
Cell transplantation is a new therapeutical approach in patients with HF after a myocardial infarction. Most of the trials used intra-coronary delivery of bone marrow stem cells, following successful stenting of the infarct-related artery. The improvement in the LVEF, reduction in size of scar tissue and reduction in cardiac volume were markers to assess the efficacy of cell therapy. Four main randomized controlled trials (RCTs) were published with positive findings (improved LVEF, improvement in regional contractility and reduction of the infarcted area). Three randomized controlled trials showed no changes in global LVEF and no changes in global or regional LV systolic function after BMSC infusion. There were no safety issues it the conducted trials. Possible reasons for the inconsistent findings are the variations in the number of delivered cells, timing of delivery after AMI and the differences in the cell isolation protocol.
read the entire text >>

18. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 12, 2016, No. 1 , , ,

In 2015 this Consensus was updated with new clinical trials data.
The original version of the Consensus on mechanical thrombectomy in AIS was approved by the European Stroke Organization (ESO) in 2014. In 2015 this Consensus was updated with new clinical trials data. The MRCLEAN trial (Multicenter Randomized Clinical trial of Endovascular Treatment in the Netherlands), the SWIFT PRIME trial (Solitaire TM With the Intention For Thrombectomy as PRIMary treatment for acute ischemic stroke), the ESCAPE trial (Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times), the REVASCAT trial (Randomized Trial of Revascularization with Solitaire FR Device versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset) are the biggest ones and give answers to many questions related to the treatment of acute stroke [8, 16].
read the entire text >>

Similar results were obtained in ESCAPE and SWIFT PRIME trials (in the latter with upper age limit of 80 years) showing bene
48%) and favorable outcomes (68% vs. 15%) as well as lower mortality (18% vs. 41%) compared to intraarterial thrombolysis [8, 9]. In MR CLEAN trial 16% of the patients were 80 years old or older. There was a positive treatment effect in this subgroup [1]. Similar results were obtained in ESCAPE and SWIFT PRIME trials (in the latter with upper age limit of 80 years) showing bene
read the entire text >>

sedation has been currently studied in four randomized trials [8].
cantly higher inhospital mortality (25%) and pneumonia (17%) compared to patients received conscious sedation (12% and 9.3%, respectively) but similar rates of SICH [14, 19]. The analysis of the thrombectomy patients in MR CLEAN showed better functional three-month outcome in the absence of general anesthesia, but the patients were not randomized to the type of anesthesia. The issue of general anesthesia vs. sedation has been currently studied in four randomized trials [8]. An expert consensus of the Neurointerventional Surgery and the Neurocritical Care Society recommends the use of general anesthesia for patients with severe agitation, low level of consciousness (GCS
read the entire text >>

In the ESCAPE and SWIFT-PRIME trials a lower ASPECTS threshold was applied – 5 and 6 points respectively [16].
t of thrombectomy for patients with ASPECTS scores of 5 or more points (5–7 points) but not with ASPECTS scores 0–4 [8]. In the ESCAPE and SWIFT-PRIME trials a lower ASPECTS threshold was applied – 5 and 6 points respectively [16].
read the entire text >>

Recent randomized clinical trials show that best medical therapy (BMT) is better than carotid endarterectomy (CEA) or carotid artery stenting (CAS) in preventing stroke.
Recent randomized clinical trials show that best medical therapy (BMT) is better than carotid endarterectomy (CEA) or carotid artery stenting (CAS) in preventing stroke. On the contrary guidelines of practice should remain unchanged. Current recommendations indicate that only ‘highly-selected‘patients should undergo CEA/CAS.
read the entire text >>

To analyze the best treatment strategy for ACAS multiple trials have been performed.
To analyze the best treatment strategy for ACAS multiple trials have been performed. The NASCET and ECST trials were important to establish the methods by which stenosis is measured for consistency among observers. By international agreement, only the distal degree of stenosis (as per the NASCET trial criteria) should be used to quantify the degree of carotid stenosis [7].
read the entire text >>

The NASCET and ECST trials were important to establish the methods by which stenosis is measured for consistency among observers.
To analyze the best treatment strategy for ACAS multiple trials have been performed. The NASCET and ECST trials were important to establish the methods by which stenosis is measured for consistency among observers. By international agreement, only the distal degree of stenosis (as per the NASCET trial criteria) should be used to quantify the degree of carotid stenosis [7].
read the entire text >>

According to these trials, about 49% of respondents recommended BMT, compared with 31% for CEA and 20% for CAS.
The Asymptomatic Carotid Surgery Trial (ACST) showed that the 10-year stroke risk in patients who underwent CEA was 10.8% compared with 16.9% in those treated with medical therapy [10]. Paradoxically, in one NEJM audit and also in one questionnaire obtained in the USA similar results were obtained [11]. According to these trials, about 49% of respondents recommended BMT, compared with 31% for CEA and 20% for CAS. In addition, Abbott proposed medical management as the best option for patients with ACAS due to the high costs of surgical intervention and associated complications [12]. Also there are patients in whom medical therapy
read the entire text >>

To date, despite numerous trials and years of clinical research, the optimal management of ACAS remains controversial.
To date, despite numerous trials and years of clinical research, the optimal management of ACAS remains controversial. There is some evidence in support of current medical management as a better and more cost-effective method of treating ACAS. Medical treatment has improved over the past three decades while CEA has had little change in efficacy and operative risk. On the other hand, there is no definitive evidence that CEA is inferior to medical treat-
read the entire text >>

Collaborative metaanalysis of randomised trials of anti-platelet therapy for prevention of death, myocardial infarction and stroke in high risk patients.
Antithrombotic Trialists Collaboration. Collaborative metaanalysis of randomised trials of anti-platelet therapy for prevention of death, myocardial infarction and stroke in high risk patients.
read the entire text >>

Carotid artery stenting vs carotid endarterectomy: meta-analysis and diversity-adjusted trial sequential analysis of randomized trials.
Bangalore S, Kumar S, Wetterslev J, Bavry AA, Gluud C, Cutlip DE, Bhatt DL. Carotid artery stenting vs carotid endarterectomy: meta-analysis and diversity-adjusted trial sequential analysis of randomized trials.
read the entire text >>

A. Natural history of carotid artery stenosis contralateral to endarterectomy: results from two randomized prospective trials.
A. Natural history of carotid artery stenosis contralateral to endarterectomy: results from two randomized prospective trials.
read the entire text >>

19. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 12, 2016, No. 2 , , ,

High-intensity focused ultrasound: Advances in technology and experimental trials support enhanced utility of focused ultrasound surgery in oncology.
Malietzis G, Monzon L, Hand J, Wasan H, Leen E, Abel M, Muhammad A, Price P, Abel P. High-intensity focused ultrasound: Advances in technology and experimental trials support enhanced utility of focused ultrasound surgery in oncology.
read the entire text >>

Larger randomized trials are needed to answer this question.
questions about the benefits of endovascular treatment of VA stenosis compared to medical therapy. Larger randomized trials are needed to answer this question. ln clinical practice vascular reconstruction by surgical or endovascular means is logically a reasonable option to improve the VB blood supply [16]. ln patients with posterior circulation TlA and stroke, the presence of VB stenosis is associated with a greatly increased risk of recurrent stroke. lt identifies a group of patients who have a risk as high as 33% in the first month after their initial event. Traditionally, posterior circulation stroke and TlA have been thought to have a lower recurrent stroke risk than other types of stroke. ln contrast, studies demonstrate that it is associated with a high early stroke risk; a metaanalysis suggests that the risk is higher than that seen in anterior circulation stroke [17].
read the entire text >>

Randomized placebo-controlled trials have shown time-dependent benefits of tPA: early treatment is associated with better outcomes.
In stroke thrombolysis, onset to treatment time can be divided into onset-to-door and door-to-needle time (DTN). The latter can be influenced by streamlining of all parts of the inhospital thrombolysis process and improves with center experience. The benefits of intravenous tissue plasminogen activator (tPA) in patients with acute ischemic stroke (AIS) are time dependent and guidelines recommend DTN time of 60 minutes or less. However, studies have found that only 11–30% of patients are treated within this time window, as per different stroke registries. Randomized placebo-controlled trials have shown time-dependent benefits of tPA: early treatment is associated with better outcomes. Within 90 minutes of symptom onset, the number needed to treat for 1 excellent outcome is 4.5; the number is 9 between 91 and 180 minutes and 14 be-
read the entire text >>

To date, no medical or surgical trials have clearly attested
To date, no medical or surgical trials have clearly attested
read the entire text >>

20. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 13, 2017, No. 1 , , ,

However, because of the small sample size, further evaluation in larger trials is needed [17].
179 patients, 58 received labetalol, 58 received lisinopril and the other 63 patients were the placebo group. There was no evidence of early neurological deterioration with active treatment, despite the significantly greater fall in systolic blood pressure within the first 24 h in this group compared with placebo. No increase in serious adverse events was reported with active treatment but 3-month mortality was halved, so the authors believe that early lowering of blood pressure with lisinopril and labetalol after acute stroke seems to be a promising approach to reduce mortality and potential disability. However, because of the small sample size, further evaluation in larger trials is needed [17].
read the entire text >>

These neutral results might be because COSSACS was underpowered owing to early termination of the trial, and support the continuation of ongoing research trials [18].
after acute mild stroke were not associated with an increase in adverse events. These neutral results might be because COSSACS was underpowered owing to early termination of the trial, and support the continuation of ongoing research trials [18]. Anderson and other INTERACT2 investigators randomly assigned 2839 patients who had had a spontaneous intracerebral hemorrhage within the previous 6 h and elevated systolic blood pressure to receive intensive treatment to lower their blood pressure (with a target systolic level of
read the entire text >>

The data from the trial will improve the precision of estimating the results (efficacy and safety) from completed trials of blood pressure management in acute stroke and provide the first large-scale randomized evidence on transdermal glyceryl trinitrate and on continuing (versus stopping) pre-stroke antihypertensive medications in AIS [21].
antihypertensive drugs if relevant, in patients with AIS and high systolic blood pressure (140−220 mmHg), are about to be issued by Bath and his collaborators in the ENOS (Efficacy of Nitric Oxide in Stroke) study. The data from the trial will improve the precision of estimating the results (efficacy and safety) from completed trials of blood pressure management in acute stroke and provide the first large-scale randomized evidence on transdermal glyceryl trinitrate and on continuing (versus stopping) pre-stroke antihypertensive medications in AIS [21].
read the entire text >>

− the lower the better − we should wait for the results of many randomized clinical trials that are being conducted at the present time, for example the EuroHYP-1: European multicentre, randomized, phase III clinical trial of therapeutic hypothermia [44].
− the lower the better − we should wait for the results of many randomized clinical trials that are being conducted at the present time, for example the EuroHYP-1: European multicentre, randomized, phase III clinical trial of therapeutic hypothermia [44]. At the present time, insufficient evidence exists to recommend hypothermia for treatment of patients with acute stroke, but
read the entire text >>

one may consider lowering body temperature as soon as it reaches 37.0 °C, but soon we shall have the results of large randomized controlled trials, and new guidelines will be issued.
one may consider lowering body temperature as soon as it reaches 37.0 °C, but soon we shall have the results of large randomized controlled trials, and new guidelines will be issued.
read the entire text >>

Clinical trials are needed to undoubtedly prove that biotransplants fit morphologically and functionally to replace the injured tissue or organ.
on the issues of three-dimensional bioprinting, which at this stage is not routinely applied in clinical practice. The method is associated with large financial costs that are unbearable for the patient. Clinical trials are needed to undoubtedly prove that biotransplants fit morphologically and functionally to replace the injured tissue or organ. There are additional requirements for the material and human resources associated with the transplantation process that are to be formulated and internationally accepted [21].
read the entire text >>

The protocol is based on the results from main randomized trials in the field of endovascular treatment of acute ischemic stroke, their advantages and disadvantages (angiographical, endovascular and clinical) to minimize the patient‘s risk.
The protocol is based on the results from main randomized trials in the field of endovascular treatment of acute ischemic stroke, their advantages and disadvantages (angiographical, endovascular and clinical) to minimize the patient‘s risk. Referred are the mandatory criteria for training and certification of endovascular specialists, indications and contraindications for the procedure, the types of methods and overall organization of the stroke units and stroke centers for interventional procedures.
read the entire text >>

Recent Endovascular Stroke Trials and Their Impact on Stroke System of Care.
Mokin M, KV. Snyder, AH. Siddiqui, EI Levy, LN Hopkins. Recent Endovascular Stroke Trials and Their Impact on Stroke System of Care.
read the entire text >>

21. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 13, 2017, No. 2 , , ,

She works as PI, national coordinator or contributor to a number of international trials.
Her scientific works include monographs, textbooks, manuals and more than 250 publications. She works as PI, national coordinator or contributor to a number of international trials. She has been a visiting lecturer and chairperson of many scientific events.
read the entire text >>

trials
trials
read the entire text >>

The present article presents the findings from recent international trials.
Mechanical thrombectomy devices have been used for treatment of acute ischemic stroke caused by brain vessel occlusion for more than ten years. The initial results were based on case reports and case series and in the last several years on registries, mainly concerning stent retrievers. The present article presents the findings from recent international trials.
read the entire text >>

Randomized controlled trials (RCT) comparing iv thrombolysis (IVT) alone with TE or IVT plus TE were not available until 2013.
Randomized controlled trials (RCT) comparing iv thrombolysis (IVT) alone with TE or IVT plus TE were not available until 2013.
read the entire text >>

The most important of these trials are the SWIFT PRIME study, the ESCAPE trial and the REVASCAT trial, all showing a clear and statistically significant superiority of TE-mostly plus IVT versus IVT alone [3, 4].
During the next half year a number of further studies were presented and mostly simultaneously published in the NEJM. The most important of these trials are the SWIFT PRIME study, the ESCAPE trial and the REVASCAT trial, all showing a clear and statistically significant superiority of TE-mostly plus IVT versus IVT alone [3, 4].
read the entire text >>

Summarizing those trials, 140 mmHg seems to remain a safe target for blood pressure management in acute ICH and avoiding strong variability of blood pressure seems also to be very important in such patients.
After ATACH II was published in 2016, most experts did not see a necessity to change the current recommendations for the clinical routine again based on this trial. ATACH, however, opened more space for discussion on blood pressure lowering in ICH, especially with respect to possible harms beyond a “sweet spot” of a safe target value. Those discussions are reinforced by recent findings of MRI in patients with ICH. A retrospective study by Prabhakaran and colleagues [44] described distant small ischemic lesions (areas of restricted diffusion on DWI imaging) and found a correlation between those lesions, extensive blood pressure reduction, and worse clinical outcome. Those findings were recently confirmed in a larger prospective cohort from the ERICH study [25], demonstrating that roughly a quarter of all spontaneous ICH patients show such lesions on MRI. Summarizing those trials, 140 mmHg seems to remain a safe target for blood pressure management in acute ICH and avoiding strong variability of blood pressure seems also to be very important in such patients. Future studies should include MRI imaging in order to estimate the role of DWI lesions and their association with blood pressure lowering.
read the entire text >>

Currently, several ongoing clinical trials investigate the use of hemostasis in spontaneous ICH using other agents, e.g.
>70 years, treatment later than 2.5 hours), could show a strong trend towards improved outcome and a twofold reduction in hematoma growth in the selected collective treated with rfVIIa [39]. On that basis the routine use of rfVIIa for treatment of ICH cannot be recommended. Currently, several ongoing clinical trials investigate the use of hemostasis in spontaneous ICH using other agents, e.g. tranexamic acid.
read the entire text >>

presented within the publication of STICH II an updated metaanalysis of randomized controlled trials on surgery in ICH.
primary endpoint did not differ between the two groups (p=0.37), in terms of mortality there was a non-significant trend in favor of the early surgery (5.6% absolute risk reduction, p=0.095). A subgroup analysis was not conclusive. Only patients with a worse prognostic estimation based on the criteria defined by the authors seemed to benefit from surgical treatment. As the study was planned to detect a difference of 12%, the statistical power was not sufficient in order to show a significant result at the level of the detected trends. Mendelow & al. presented within the publication of STICH II an updated metaanalysis of randomized controlled trials on surgery in ICH. In this meta-analysis the authors included totally 15 studies of different size and quality published between 1961 and 2013. Most of the patients for this meta-analysis were contributed by both STICH trials. In summary, a significant benefit was found in favor of surgical treatment with an OR of 0.74 (95% CI 0.64-0.86, p
read the entire text >>

Most of the patients for this meta-analysis were contributed by both STICH trials.
Only patients with a worse prognostic estimation based on the criteria defined by the authors seemed to benefit from surgical treatment. As the study was planned to detect a difference of 12%, the statistical power was not sufficient in order to show a significant result at the level of the detected trends. Mendelow & al. presented within the publication of STICH II an updated metaanalysis of randomized controlled trials on surgery in ICH. In this meta-analysis the authors included totally 15 studies of different size and quality published between 1961 and 2013. Most of the patients for this meta-analysis were contributed by both STICH trials. In summary, a significant benefit was found in favor of surgical treatment with an OR of 0.74 (95% CI 0.64-0.86, p
read the entire text >>

Hypothermia in ICH is currently being further investigated in ongoing trials [26].
Hypothermia has been subject of research in experimental ICH models in the recent past and several rodent studies have reported reduction in inflammation, oxidative damage, blood brain barrier disruption and perihemorrhagic edema using prolonged therapeutic hypothermia [12, 24, 35]. The clinical application of mild therapeutic hypothermia (35°C for up to 10 days) in patients with large ICH has been investigated by one research group from Erlangen, Germany [27, 52]. The authors of those studies describe a marked reduction of perihemorrhagic edema evolution and a lower mortality in treated patients as compared to historical controls. Hypothermia in ICH is currently being further investigated in ongoing trials [26].
read the entire text >>

Low quality data from small, mostly nonrandomized clinical trials on IVF in patients with IVH that have accumulated over the past few decades show trends of reduction of mortality and improvement of clinical outcome, as compared to EVD alone or conservative treatment (no EVD) [48].
EVD alone is often not sufficient, because especially in more severely affected patients the catheter is frequently obstructed by blood clots [1]. Although it seems paradoxical at first glance to treat a hemorrhage with fibrinolytics, the concept of intraventricular fibrinolysis (IVF) has been tested in the experimental setting since the 1980s and first successful treatments in clinical cases have been reported in the early 1990s [48]. The rationale of this treatment consists in the degradation of the ventricular clot by injection of low dosed fibrinolytic substances (e.g. rtPA or urokinase) into the EVD at a time point, where the bleeding has already stopped and the clot is consolidated. This way the functionality of the drain can be kept and the degradation and drainage of the intraventricular clot can be fastened. Low quality data from small, mostly nonrandomized clinical trials on IVF in patients with IVH that have accumulated over the past few decades show trends of reduction of mortality and improvement of clinical outcome, as compared to EVD alone or conservative treatment (no EVD) [48]. A large phase III randomized, blinded, placebo-controlled clinical trial (CLEAR III) investigated the efficacy of IVF in 500 patients with IVH and acute obstructive hydrocephalus [17]. The study finished recruiting patients in 2014 and was recently published. The primary outcome of the trial, namely the difference in the proportion of patients with good functional outcome (mRS 0-3) 180 days after the event, showed no statistically significant difference between intraventricular rtPA and placebo. There was, however, a significant reduction in mortality (absolute risk reduction of 10%, p=0.006) in favor of the rtPA group. In a subgroup analysis patients with more severe IVH (>20 ml) from which
read the entire text >>

So far, no multicenter trials in the field of neurology are published.
Myosonology is used alone or in combination with other diagnostic or therapeutic methods in different experimental research protocols in vivo and in vitro. So far, no multicenter trials in the field of neurology are published.
read the entire text >>

Further multicenter trials are needed to establish international guidelines for application of myosonology in the field of neurology and related neuromuscular disorders.
Myosonology seems to become a powerful tool for neurologists and physiotherapists in their every day clinical practice. The multimodal ultrasound imaging gives reliable non-invasive information for dimension, morphological changes and functional characteristics of the target muscle’s areas in normal and pathological conditions. The myosonological patterns reflect the degree of muscle atrophy, fat tissue infiltration and fibrosis, which appear to correlate with the severity, the topic and the myoarchitectonics of muscle lesion. However, why and when to apply myosonology for clinical usage depends on the level of competency (technical and human resources) of each laboratory and the purpose of the particular research protocol. Further multicenter trials are needed to establish international guidelines for application of myosonology in the field of neurology and related neuromuscular disorders.
read the entire text >>

N. Effect of aerobic exercise intensity on glycemic control in type 2 diabetes: a meta-analysis of head-to-head randomized trials.
N. Effect of aerobic exercise intensity on glycemic control in type 2 diabetes: a meta-analysis of head-to-head randomized trials.
read the entire text >>

Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP, Brott T, Frankel M, Grotta JC, Haley EC Jr, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.
read the entire text >>

Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials.
Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W, Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials.
read the entire text >>

22. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 14, 2018, No. 1 , , ,

trials, emphasizing the importance of specialized rehabilitation, have been used to create up-todate guidelines for its use.
trials, emphasizing the importance of specialized rehabilitation, have been used to create up-todate guidelines for its use. Patients usually have impaired physical capacity and physical activity several years before surgery, which in combination with bed rest after surgery determines the need for timely rehabilitation. It has been established that rehabilitation doesn’t harm the patient in the postoperative period and has positive physical and psychological effects [10, 14].
read the entire text >>

Trials
Trials
read the entire text >>

23. NEUROSONOLOGY AND CEREBRAL HEMODYNAMICS, vol. 14, 2018, No. 2 , , ,

Clinical trials for preventing post stroke cognitive impairment.
Ankolekar S, Geeganage C, Anderton P, Hogg C, Bath PM. Clinical trials for preventing post stroke cognitive impairment.
read the entire text >>

The recommendations in the guidelines on the management of acute ischemic stroke are based on results of a number of clinical trials
The recommendations in the guidelines on the management of acute ischemic stroke are based on results of a number of clinical trials
read the entire text >>

It was proven with prospective trials, that the IMT could be decreased by appropriate treatment.
Age, hypertension, hyperlipidemia, smoking, alcohol influence the intima-media thickness (IMT), which should be less than 1 mm in healthy persons. It was proven with prospective trials, that the IMT could be decreased by appropriate treatment. The positive effect of statins, antihypertensive drugs have been proven. Some statins and antihypertensive drugs resulted in significant decrease of IMT thickness after one or 2 years therapy while others did not have beneficial effect. Besides, the majority of trials detected significant positive correlation between the reversal of IMT and the risk of vascular events. The advantages of carotid IMT trials are: a/ measure the effect of a new drug onto the IMT; b/ the results (needs much shorter time than a morbidity-mortality trial) may be decisive to start or refute a long-lasting and expensive morbidity trial on drugs aimed on atherosclerosis.
read the entire text >>

Besides, the majority of trials detected significant positive correlation between the reversal of IMT and the risk of vascular events.
Age, hypertension, hyperlipidemia, smoking, alcohol influence the intima-media thickness (IMT), which should be less than 1 mm in healthy persons. It was proven with prospective trials, that the IMT could be decreased by appropriate treatment. The positive effect of statins, antihypertensive drugs have been proven. Some statins and antihypertensive drugs resulted in significant decrease of IMT thickness after one or 2 years therapy while others did not have beneficial effect. Besides, the majority of trials detected significant positive correlation between the reversal of IMT and the risk of vascular events. The advantages of carotid IMT trials are: a/ measure the effect of a new drug onto the IMT; b/ the results (needs much shorter time than a morbidity-mortality trial) may be decisive to start or refute a long-lasting and expensive morbidity trial on drugs aimed on atherosclerosis.
read the entire text >>

The advantages of carotid IMT trials are: a/ measure the effect of a new drug onto the IMT; b/ the results (needs much shorter time than a morbidity-mortality trial) may be decisive to start or refute a long-lasting and expensive morbidity trial on drugs aimed on atherosclerosis.
Age, hypertension, hyperlipidemia, smoking, alcohol influence the intima-media thickness (IMT), which should be less than 1 mm in healthy persons. It was proven with prospective trials, that the IMT could be decreased by appropriate treatment. The positive effect of statins, antihypertensive drugs have been proven. Some statins and antihypertensive drugs resulted in significant decrease of IMT thickness after one or 2 years therapy while others did not have beneficial effect. Besides, the majority of trials detected significant positive correlation between the reversal of IMT and the risk of vascular events. The advantages of carotid IMT trials are: a/ measure the effect of a new drug onto the IMT; b/ the results (needs much shorter time than a morbidity-mortality trial) may be decisive to start or refute a long-lasting and expensive morbidity trial on drugs aimed on atherosclerosis.
read the entire text >>

The randomized trials successfully evaluated the effect of different anticoagulants (e.g.
Transcranial Doppler (TCD) is also useful for evaluation of the efficacy of pharmacotherapy not only in subarachnoid bleeding but also in ischemic stroke risk patients. The microembolic signals are accepted surrogate marker for future stroke risk and have been used to show treatment efficacy in different clinical conditions (TIA, carotid stenosis, carotid endarterectomy, coronary bypass surgery and during some intravascular interventions). The randomized trials successfully evaluated the effect of different anticoagulants (e.g. heparin vs. LMWH), mono vs dual antiplatelet therapy in stroke or stroke risk patients.
read the entire text >>

She is Principal Investigator, National Coordinator or contributor to a number of international trials in the field of stroke, multiple sclerosis, epilepsy and Parkinson’s disease.
new directions in ultrasound diagnostics of the nervous system in Bulgaria and abroad. She is Principal Investigator, National Coordinator or contributor to a number of international trials in the field of stroke, multiple sclerosis, epilepsy and Parkinson’s disease. She has been a guest lecturer in Serbia, Croatia, Finland, Mexico and Georgia and chairperson in many national and international scientific events.
read the entire text >>

Back to Top