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NCT ID: NCT03196596 Completed - Clinical trials for Aortic Valve Stenosis

Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)

TAVIguide
Start date: May 23, 2017
Phase:
Study type: Observational

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient. The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.

NCT ID: NCT03196284 Completed - Clinical trials for Congenital Bleeding Disorder

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

explorer™4
Start date: August 10, 2017
Phase: Phase 2
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.

NCT ID: NCT03192917 Completed - Clinical trials for Erectile Dysfunction

Low-energy Extracorporeal Shockwave Treatment for Patients After Radical Prostatectomy

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this project is to verify the relationship between low intensity shock wave treatment (LI-SWT) and increased scores in self-assessment regarding to erectile function (ED) and sexual intercourse, in patients, who has undergone a radical prostatectomy (RP). The data will be obtained from patients using international accepted sexual questionnaires prior to the LI-SWT and 5, 12 and 24 weeks following treatment.

NCT ID: NCT03192813 Completed - Clinical trials for Aortic Valve Stenosis

Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II

SCOPE II
Start date: April 20, 2017
Phase:
Study type: Observational

Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

NCT ID: NCT03191786 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy

IPSOS
Start date: September 11, 2017
Phase: Phase 3
Study type: Interventional

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

NCT ID: NCT03190707 Completed - Depression Clinical Trials

A Good Start to Life - an Early Cross-sectorial Intervention

Start date: June 16, 2017
Phase: N/A
Study type: Interventional

The aim of the project is to develop and evaluate an interdisciplinary and cross-sectorial intervention targeting pregnant women with psychosocial vulnerabilities. The objective is to 1) detect depression, anxiety and personality disorders in the pregnant women, 2) to increase knowledge sharing across the health care sectors and 3) strengthen the parents' parenting skills and thereby support a secure attachment between parents and child and thus promoting the child's well-being. The overriding hypothesis is that an early multi-stringed, interdisciplinary and cross-sectorial intervention, with a long-term perspective from the early pregnancy throughout the child's first years of life, can effectively prevent disorders in the parent-child relation. The approach is to detect and treat depression, anxiety and personality disorders in the mother and strengthen the parents' parenting skills in families with maternal psychosocial vulnerabilities. The hypothesis indicates that the over-all intervention will result in improved interaction between child and parents which will make it possible to detect higher maternal sensitivity and a higher level of well-being among both children and parents in the intervention group compared to the control group. The projects' specific hypotheses are; - A systematic screening for anxiety, depression and personality disorders in the midwifery consultation will imply more pregnant women with symptoms of anxiety, depression and personality disorders being detected and offered treatment in the intervention group compared to the control group. - Knowledge sharing across health care sectors will improve by the implementation of a joint consultation involving the vulnerable pregnant woman/families, the midwife and the health visitor and by a systematic transmission of information when the woman leaves the post-natal ward and is transferred to the health visitor. - Parental skills in psychosocial vulnerable pregnant women and their partners can be strengthened by a parental training program and by education and dialogue about perceived challenges and breast-feeding. Parents in the intervention group will therefore gain greater knowledge on what it takes to make breast-feeding work successfully, be able to interact more appropriate with their children, and improve their mentalization skills and experience less stress compared to parents in the control group.

NCT ID: NCT03189719 Completed - Clinical trials for Esophageal Neoplasms

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

Start date: July 25, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The overall primary efficacy hypotheses are as follows: 1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score [CPS] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy. 2. In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.

NCT ID: NCT03188445 Completed - Clinical trials for Iron Deficiency Anemia of Pregnancy

Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.

Start date: July 11, 2017
Phase: Phase 4
Study type: Interventional

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

NCT ID: NCT03183960 Completed - Quality of Life Clinical Trials

Stroke - 65 Plus. Continued Active Life.

Stroke65+
Start date: June 15, 2017
Phase: N/A
Study type: Interventional

Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a Danish region with 1.2 inhabitants have in cooperation with health professionals from a specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked through and is still working with an iterative process in the development of a novel self-management support intervention for elderly stroke individuals.The intervention is going to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the project named 'Stroke - 65 plus. Continued active life'.

NCT ID: NCT03181191 Completed - Clinical trials for Glucose Metabolism Disorders

The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion

Start date: April 27, 2017
Phase: N/A
Study type: Interventional

Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion