Waiting list studies

The results of this study showed that we were right about the effects of the therapeutic relationship. Six weeks after the beginning of treatment, patients given an enhanced therapeutic relationship reported significantly greater symptom reduction and better quality of life than those given the low-dose relationship, despite the fact that the difference in treatment was limited to the initial interview. Those in the wait-list group showed the least improvement of all.6... 

An outline of the data from non-clinical studies must be submitted to the PMDA with the protocol for the proposed clinical study before commencing the clinical trial. A notification is required for each protocol. The list of items required for Clinical Trial Plan Notification is shown in Table 23.4. Furthermore, supplementary data must be added on entry to subsequent clinical phases, that is, general clinical trials and comparative trials. Such data are reviewed by the PMDA, and for this purpose the sponsor must wait for 30 days after submitting the initial notification before executing a contract with the medical institute. For a subsequent notification, the review period is reduced to 14 days. The notification also... 

This study had very little impact on generating public or political concern to set up a regulatory authority. However, the appearance of two publications by the BMA concerning certain proprietary medicines, entitled Secret Remedies (1909) and More Secret Remedies (1912), caused a Parliamentary Select Committee on Patent Medicines to be set up. This Select Committee reported in 1914, but World War I intervened and all the proposed legislation was shelved. It is worth listing several of the recommendations of this Committee, some of which had to wait until the Medicines Act (1968) controlled and kept standards under review, and many of these became internationally recognized. 

Patients waiting for heart transplant may be a potential population that would benefit from ICD implant (217-219). Up to 30% of patients on heart transplant lists die waiting for a transplant, and often the death is sudden and presumed arrhythmic. In one study of 978 patients from 12 institutions awaiting heart transplant, the ICD seemed to be helpful. This patient population included UNOS Status II patients (not in the intensive care unit on intravenous inotropic... 

In a retrospective study of 60 patients listed for cardiac transplantation, pre-treatment at home with intravenous milrinone was an effective strategy as a bridge to transplant if the waiting time was short (mean 60, range 9-257 days) [11 ]. There were adverse effects potentially due to milrinone in two cases syncopal episodes and discharge of an automated implantable cardioverter defibrillator. 

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