Music is probably the only real magic I have encountered in my life. There's not some trick involved with it. It's pure and it's real. It moves, it heals, it communicates and does all these incredible things. Sign in or sign up and post using a HubPages Network account. Comments are not for promoting your articles or other sites.
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my life STUCK IN THE 80s
Marshall Fish more. They took the credit for your second symphony. Rewritten by machine and new technology, and now I understand the problems you can see. Album: Ph. Little Suzi's on the up, looking for a get-away Ruby trying to bring her down, still looking for another way Little Suzi's on the up, heading for the spotlight Ruby finally gets up, lookin' for some quiet nights — Ph. It's so funny why we don't talk anymore. But I ain't losing sleep and I ain't counting sheep.
Her father was Ken Lane, songwriter and pianist for Dean Martin. From to she was married to future Police lead guitarist Andy Summers. In the s she was more influenced by the growing punk rock and new wave genres. He finally hit it big with "When Things Go Wrong. Your deep emotions, inside yourself They're hard to face but you must try You had your feelings for the one you love You got me wondering why — Robin Lane and the Chartbusters, "When Things Go Wrong".
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It was the first video by a Canadian recording artist ever played on MTV. The final chorus of the album version includes the song's title in French: "Seulement entre toi et moi. In the U. It is the band's only album to feature guitarist Dennis Stratton. The title track was the first major metal music video to appear on MTV. If heavy metal bands ruled the world, we'd be a lot better off. Billboard Hot The single was certified Platinum for U. It peaked at number seven in the U. Singles Chart. The song is from the point of view of a man who is in a failing relationship, and is trying to convince himself his situation will improve once the one he loved moves on.
It has been praised by critics as a highlight of Pretenders II. He is an American jazz guitarist. He's been described as a "flawless musical chameleon" by Allmusic. Ritenour has won one Grammy with a sum of sixteen nominations.
As part of the therapeutic trial we will collect biosamples which will be used for the analysis of pharmacodynamics, disease progression, genotyping and potentially for future studies. EDTA-blood, serum, plasma, urine, and saliva will be collected from all individuals at specified time points. Individual alterations of the biosample collection and analysis plan will not be classified as violations of the general study protocol. The investigator should report any AE occurring in this time period that is believed to be related to study drug or protocol-specified procedure.
All SAE for which a causal relationship with the administration of study medication may not be ruled out serious adverse reactions, SAR need to be defined and reported as suspected unexpected serious adverse reactions SUSAR. Once an AE is detected, it should be followed until its resolution or stabilization and assessment should be made at each visit or more frequently, if necessary of any changes in severity, the suspected relationship to the study, the interventions required to treat it and the outcome.
All SAE will be reviewed by an independent medical monitor, who will be independent from the reporting investigator, the trial sponsor and the coordinating investigator. The investigator must carry out a causality assessment for all AEs. This type of SAE must be reported by the CRO to the appropriate national health authority and ethics committees within 15 days; fatal or life-threatening events must be reported within 7 days.
The CRO will immediately, within 15 days after it becomes known, report all circumstances that require a revision of the risk-benefit analysis to the relevant ethics committees and the federal authorities. This especially includes:. The study will be monitored by an independent safety monitoring board SMB , which will come together once before the start of the trial and then hold telephone conferences approximately every 3 months during the trial in order to review trial progress, safety data, and adherence to protocol, with the frequency of meetings depending on the rate of recruitment and safety issues.
The documentation of the study data in adherence to the Good Clinical Practice GCP -guidelines and the clinical trial protocol is the responsibility of the local investigator. Original data source documents remain in hospital medical records and information on the eCRF must be traceable and consistent with the original data. Source documents are e. Original written informed consent signed by the patient is kept by the investigator and a signed copy will be given to the patient. No information in source documents about the identity of the patients will be disclosed.
All data collected in this study must be entered in an eCRF which has to be completed by the investigator or authorized trial personnel and signed by the principle investigator. This also applies for those patients who do not complete the study. If a patient withdraws from the study, the reason must be recorded in the eCRF. The investigator is responsible for ensuring the accuracy, completeness, and timeliness of all data reported to the sponsor in the eCRFs and in all required reports. After database lock, the principal investigator will receive data on an electronic device that includes the investigational site data for archiving in the Investigator Site File ISF.
The evaluation of the data takes place by programmed validity and consistency checks. Monitoring activities are performed to ensure that the trial is conducted in accordance with the trial protocol, the principles of GCP, and local legislation. A monitoring manual describing in detail the scope of the monitoring activities will be prepared. A monitoring visit report is prepared for each visit describing the progress of the clinical trial and all identified problems.
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and consistent with the principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible.
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Prior to study start the following documents will be obtained:. Irrespective of study outcome, the results will be presented during scientific symposia and published on www. The Swiss center in St.
Gallen is the largest ALS clinic in Switzerland. In addition, an associated center in Warsaw without explicit funding through E-Rare and thus outside of the formal trial protocol will recruit patients with the same inclusion and exclusion criteria for a biosample collection, but without treatment. Safety analyses will be performed at the local laboratories at each center.
Multiple other research labs are foreseen for the evaluation of liquid biomarkers e. In addition, we will attempt to genotype each patient by whole genome sequencing, which will be performed in collaboration with the CReATe Consortium. A sample size of patients i. Expected are high proportions of tolerability and safety in which case the confidence interval becomes narrower. If the proportion is for instance 0. Calculations were carried out using the software nQuery 4. The study will yield information about safety, tolerability, and efficacy.
The main focus of the primary analysis is to determine whether either one or both doses are safe and tolerable. Each patient will be treated with fasudil or placebo over 45 min twice a day for 20 days. Significant drug intolerance will result in stopping the infusion and termination of the trial participation for this patient.
Subsequent analyses will model tolerability and safety in logistic regressions adjusting for randomization stratification factors and important prognostic factors assessed at baseline. Primary analyses of safety and tolerability will be carried out on the ITT population. For the purpose of the tolerability analyses, subjects who discontinue during the treatment period will be considered as worst case, i. If a number of patients withdraw from the study following completion of the treatment period, there observations will be dealt with as independent right censoring and the time to first drug-related SAE will be considered as primary endpoint.
Subsequent analyses will model time to first drug-related SAE in Cox proportional hazard regressions adjusting for randomization stratification factors and important prognostic factors assessed at baseline.
Differences between both analyses will be reported and evaluated in detail. The error terms are assumed to follow a multivariate normal distribution with unstructured covariance. Survival time will be used as a secondary endpoint. The Kaplan-Meier method will be applied to estimate the survival probabilities in each group.
Subjects will be right-censored at end of their follow-up. Pairwise group comparisons against placebo will be analyzed using exact log rank tests. Cox proportional hazards regression will be carried out if there are a sufficient number of events. Disease-modification is an urgent need for the treatment of ALS. Although a multitude of different pathomechanisms are thought to contribute to disease progression, only the glutamate antagonist riluzole and the antioxidant edaravone have been approved so far, both with limited therapeutic potential.
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Novel drugs should thus target different, preferentially yet unaddressed mechanisms and ideally act in an additive or even synergistic manner with both licensed substances. ROCK inhibition appears as a promising novel approach in this respect acting on multiple pathomechanisms: it has been shown to increase axonal regeneration, attenuate neuronal cell death, modulate microglial activity and beneficially affect survival and motor function in mouse models of ALS.
Several ROCK inhibitors with different chemical backbones have been developed 19 , but only fasudil and ripasudil have been licensed for clinical use so far.