RAYNAUD'S TREATMENT STUDY-CLINICAL COORDINATING CENTER

承包商应作为临床协调中心参与， 药物和非药物的随机临床试验 雷诺综合征的治疗方法 这项研究的主要目标是 以确定原发性雷诺氏综合征的最佳治疗方法， 特别是关于疗程的疗效和受益持续时间 温度生物反馈治疗。 此外，该研究将 评估生物反馈方法在硬皮病前的有效性 雷诺氏，估计患者的比例谁有原发性和 第二种形式的障碍，并建立新的信息， 关于情绪反应在症状发作中的作用。 的 本试验中开发的信息可用于确定相对 药物和非药物治疗的成本效益。 该研究将包括约480名来自 五个临床单位。 潜在参与者将接受 医学评估以排除患有其他疾病的患者。 细节 选择标准、随机化程序、治疗和评估 将根据最终方案确定治疗疗效 由雷诺治疗研究指导委员会制定，包括 参加研究的所有实体的代表。 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.