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IMPROVE: Evaluation of a combined lifestyle intervention program to improve quality of life in long-term ICU-survivors

Evaluation of the effects of a integrative lifestyle intervention program on health related quality of life after ICU-admission.

Pyloric Endoscopic Myotomy as treatment for patients with symptom of gastric outlet obstruction after oesophagectomy with gastric conduit.

Primary objectives 1. To evaluate the efficacy, feasibility and safety of G-POEM in patients with symptoms delayed gastric emptying after oesophagectomy with gastric tube reconstruction, based subsequently on the clinical success rate at 3 months,…

Blink reflex changes after GON-injection in cluster headache: Clinical and pathophysiological implications.

To investigate if the GON-injection affects trigeminal threshold and transmission using the R2 component of the blink reflex.

The treatment of venous thromboembolism with edoxaban in patients with cirrhosis, a pharmacokinetic study.

To assess the safety and effect of edoxaban in Chil-Pugh B cirrhosis.

Preservation of both cruciate ligaments as essential step to the forgotten knee. Do we need the anterior cruciate
ligament for better functional outcomes?
A randomized controlled gait analysis trial

Primary Objective:To evaluate tibia rotation after TKA with the Vanguard total knee system with either the XP tibia implant compared to thestandard CR tibia implant.Secondary Objective:Comparing operative, clinical and radiological outcome of either…

DIStal gastriC bypass Outcome in Revision SurgEry after roux-en-y gastric bypass

The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM…

Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16)

Study CKJX839C12301 (ORION-16) is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (aged 12 to <18 years) with HeFH and LDL-C >130 mg/dL (3.4 mmol/L). The use of inclisiran…

A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis.

Primary: To determine the efficacy of SAR442168 compared to a daily dose of 14 mgteriflunomide (Aubagio) in decreasing relapses in RMS.Secondary:1. To evaluate safety, tolerability, and efficacy of SAR442168 compared to placebo on clinical endpoints…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis

Primary objective: To evaluate the effect of navitoclax in combination with ruxolitinib on splenomegaly response when compared to ruxolitinib in subjects with myelofibrosis.Secondary objectives:• To evaluate the effect of navitoclax in combination…

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

Treatment of Hemorrhoids: Rubber band ligation Or Sclerotherapy

We want to compare the effectiveness of sclerotherapy and rubberband ligation when it comes to symptoms. We will secondarily consider patient satisfaction, complications and recurrences. We hypothesize that both treatments are equally effective.

A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

The anti-TIM-3 monoclonal antibody MBG453 is a novel immunotherapeutic agent with promising activity seen in AML and MDS. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with…

Study to Evaluate Boston Scientific VerciseTM CartesiaTM 16-contact Directional Lead (X/HX) with Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson*s Disease (PD)

To document patient outcomes including effectiveness for Boston Scientific Corporation*s VerciseTM CartesiaTM 16-contact Directional Lead (X/HX) with Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson*s Disease (PD).

Aerobic fitness or Muscle mass training to Improve Colorectal cancer Outcomes (AMICO): to study safe and feasible exercise dosages (phase 2) and the effects of exercise on chemotherapy dose modifications and progression free survival (phase 3) in patients with metastatic colorectal cancer.

Phase 2 pilot-study: to examine feasible exercise dosages in patients with mCRC and collect data on preliminary effects on clinical outcomes.Phase 3 trial: to collect data on the efficacy of exercise on 1) chemotherapy dose modifications and 2)…

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects With Alzheimer*s Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Primary objective:To evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e., previously treated…

Deep brain stimulation of the medial forebrain bundle for patients with treatment-resistant depression

Establishing efficacy of MFB DBS for TRD by comparing active DBS with sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life, cost-effectiveness, (neuro)psychological and neuroimaging measures.

Preventive Cognitive Therapy with Neurocognitive Remediation Therapy for partially remitted depressed patients

To investigate the added effectiveness of Preventive Cognitive Therapy (PCT) with oNCRT as compared to PCT on depressive symptomatology over a one-year period in 115 partially remitted depressed patients. We hypothesize that oNCRT is able to augment…

Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases

This study has been transitioned to CTIS with ID 2024-515525-28-00 check the CTIS register for the current data. The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with standard systemic chemotherapy…

A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Given the limited effectiveness of available EGFR TKIs in patients with NSCLC with EGFR exon 20 insertion mutations, this subset patient population is routinely treated with chemotherapy, similar to patients with no driver mutations (ie, WT EGFR).…

SAFE-CAB

A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass Grafting (SAFE-CAB)