RAYNAUD'S DISEASE TREATMENT

承包商应作为临床协调中心参与 药物治疗与非药物治疗的随机临床试验 雷诺氏综合征的治疗。该研究的主要目标是 为了确定治疗原发雷诺综合征的最佳疗法， 尤其是关于从课程中受益的有效性和持续时间 温度生物反馈治疗。此外，这项研究将 生物反馈法在硬皮病前治疗中的疗效评价 Raynaud‘s，估计患有原发性和多发性骨髓瘤的患者比例 第二种形式的障碍，并建立新的信息与 尊重情绪反应在症状出现中的作用。这个 在这项试验中开发的信息可以用来确定亲属 药物治疗和非药物治疗的成本效益。 这项研究将由大约480名来自 五个参与的临床单位。未来的参与者将接受 排除其他病症患者的医学评估。详细信息 选择标准、随机化程序、治疗和评估 治疗效果的百分比将根据最终方案确定 由雷诺治疗研究指导委员会开发，包括 所有参与这项研究的实体的代表。 协调最终研究设计、数据收集及其分析 将通过该承包商进行。

The contractor shall participate as the clinical coordinating center for the randomized clinical trial of pharmacological and non-pharmacological treatments for Raynaud's syndrome. The primary goals of the study are to determine the best therapies for primary Raynaud's syndrome, particularly regarding the efficacy and duration of benefit from a course of temperature biofeedback treatment. Additionally, the study will evaluate the efficacy of the biofeedback approach in pre-sclerodermal Raynaud's, estimate the proportions of patients who have the primary and secondary form of the disorder, and establish new information with respect to the role of emotional reactivity in onset of symptoms. The information developed in this trial could be used to establish relative cost-effectiveness of pharmacological and non-pharmacological treatments. The study will consist of approximately 480 recruited participants from five participating clinical units. Prospective participants will undergo a medical evaluation to exclude patients with other conditions. Details of selection criteria, randomization procedures, treatment and assessment of treatment efficacy will be determined according to a final protocol developed by the Raynaud's Treatment Study steering committee, consisting of representatives from all entities participating in the study. Coordination of the final study design, data collection and its analysis will be conducted through this contractor.