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Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics , Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

Phase 1Primary ObjectivesTo assess the safety and tolerability of orally administered CLN-081 monotherapy.To define the maximum tolerated dose (MTD) of orally administered CLN-081 monotherapy.Secondary ObjectivesTo assess the anti-tumor activity.To…

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up and a long-term extension (CONTRAIL I).

This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib

The primary objective of the study is to evaluate the percentage of subjects with at least 35%spleen volume reduction in the fedratinib and the BAT arms.The secondary objectives are:• To evaluate the percentage of subjects with at least 50%…

Dorsal dislocations or hyperextension injuries with a volar plate avulsion of the proximal interphalangeal joint, conservative treatment with or without supervised hand-therapy?

To compare the functional outcome and cost-effectiveness of self-management exercise regimen versus supervised hand-physiotherapy. The patient group exists of adults who are treated conservatively because of dorsal dislocation or hyperextension…

Cardiac changes after stereotactic radiotherapy for early stage NSCLC cancer or lung metastasis - HALO

We aim to optimize the radiation treatment of early stage lung cancer patients. Cardiac sparing is possible, but it comes at the cost of an increased mean lung dose. Without proof of cardiac toxicity, cardiac sparing will not be (routinely) applied…

B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues Analysis 2

The objective of this study is to investigate of inflammatory tissues of patients with SSj, CLE and SSc contain autoreactive B and T cell expansions that are differently activated compared to other B and T cell expansions in patients with SSj, CLE…

Effectiveness of Small Size Interarcuair Decompression versus Extended Decompression in patients with intermittent neurogenic claudication (SIZE-study): a multi-centre, double-blinded randomized controlled trial

Primary Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with INC caused by LSS. Secondary Objective(s): To investigate whether small size interarcuair decompression…

Efficiency of a blended care version of an effective diabetes diet

Primary Objective: 1. What is the efficiency of a blended care version of the POWER diet (Blended POWER), compared to the POWER diet used in usual care (usual care POWER program): is Blended POWER equally effective in reducing weight after 1 year in…

Open-label, multicenter study of the 18F labeled PET/CT (positron emission tomography / computed tomography) tracer BAY 86-9596 following a single intravenous administration of 200 or 300 MBq (corresponding to <= 18 µg mass dose), for evaluation of radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers (200 MBq) as well as investigation of safety, tolerability and diagnostic performance in patients (300 MBq) with non small cell long cancer, breast cancer, hea

Primary objective:Explorative investigation of the tumor detection rate with BAY 86-9596 in comparison to that of 18F-fluorodeoxyglucose (FDG)Secondary objectives:- Determination of radiation dosimetry and pharmacokinetics of BAY 86-9596 in healthy…

Functional analysis of molecular mechanisms underlying parasympathetic regulation of human adipose

To characterize the molecular mechanisms underlying parasympathetic regulation of adipose tissue.

BIOTRONIKS-Safety and Clinical Performance of the First Drug-Eluting Generation Absorbable Metal Stent In Patients with de Novo Lesions in Native Coronary Arteries (BIOSOLVE-I study)

To evaluate safety and clinical performance of the investigation product (drug-eluting absorbable metal stent system)