9 results
The aim of the RHINO trial is to compare the effect of parathyroidectomy and cinacalcet treatment on quality of life in end-stage renal disease patients with hyperparathyroidism and to evaluate cost-effectiveness. The aim of this pilot study is to…
The primary objective of this multicenter, parallel design, prospective, randomized clinical trial, with repeated observations over time, is to compare the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT based on an open…
1. What are the effects of cinacalcet on clinical and biochemical parameters, including bone turnover markers, in patients with primary hyperparathyroidism due to a MEN-I mutation?2. What are the effects of cinacalcet on bone mineral density and…
Secondary HPT is common in people with CKD. Patients with secondary HPT often have high PTH levels and may develop large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause…
Protocol section 2.1 and 2.2
To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…
The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…
The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…
The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…