There are about 11304 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to assess the safety and biological activity of ATYR1940 in participants with LGMD2B and FSHD.
No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated. The purpose of this study is to determine, whether diet composition of carbohydrate affects the glycogen stores in the liver and affects the glucose response of glucagon during hypoglycaemia. HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of low-dose glucagon is not associated with diet carbohydrate content. AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet influence the glycaemic response of low-dose glucagon in patients with insulin pump treated type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose excursions. DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After participants have given an informed consent, they will go through four steps: 1) screening visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study visit and 4) second meal intervention for one week finalizing with another study visit.
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.
The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.
The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.
The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.
Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors. To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926 Secondary Objectives: To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites. To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients. To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).
To evaluate the natural history of visual function in subjects with IRD phenotypically diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or LRAT gene mutations.
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit. Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.
Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.