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NCT ID: NCT03424941 Active, not recruiting - Aortic Stenosis Clinical Trials

The TransCatheter Valve and Vessels Trial

TCW
Start date: May 31, 2018
Phase: N/A
Study type: Interventional

The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

NCT ID: NCT03417804 Completed - Clinical trials for Neuromuscular Blockade

Incidence of Postoperative Residual Neuromuscular Blockade in Portugal

Start date: June 18, 2018
Phase:
Study type: Observational

This is an epidemiological multicenter, observational, prospective study, designed to determine the incidence of postoperative residual neuromuscular blockade - defined by a TOF (train-of-four) ratio < 0.9 - at PACU arrival. Subjects aged at least 18 years old (n=360) admitted for different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents will be included.

NCT ID: NCT03411668 Completed - Clinical trials for Evidence-Based Nursing

EBP Educational Programme in Nursing Students' EBP Beliefs and Knowledge, and the Extent of Their EBP Implementation

Start date: February 14, 2018
Phase: N/A
Study type: Interventional

Evidence-based practice (EBP) prevents unsafety/inefficiency and improves healthcare quality. However, EBP implementation and sustainment are challenging for healthcare organizations and providers considering gaps between research and practice. An educational preparation of the future healthcare professionals can minimize these gaps. Thus, it is mandatory that undergraduate curricula in health sciences, namely in nursing, promote an EBP culture so that future health professionals use it into clinical practice. Within the Portuguese context, there is no available scientific literature about the current state of EBP integration in the undergraduate nursing curricula. Thereby, the investigators intend to verify if an EBP educational programme would be successful in improving the undergraduate nursing students' EBP knowledge and beliefs and, and the extent of their EBP implementation This will be tested using a prospective cluster randomized control trial with two-armed parallel group design.

NCT ID: NCT03410693 Completed - Clinical trials for Carcinoma, Transitional Cell

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

FORT-1
Start date: May 31, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

NCT ID: NCT03409315 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients

PERFECT
Start date: February 10, 2018
Phase:
Study type: Observational

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice. In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.

NCT ID: NCT03407027 Enrolling by invitation - Low Back Pain Clinical Trials

Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

Start date: November 1, 2017
Phase: Phase 4
Study type: Interventional

This study has the primary goal of evaluating the efficacy of corticoid infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.

NCT ID: NCT03402841 Completed - Clinical trials for Non-Germline BRCA Mutated Ovarian Cancer

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

OPINION
Start date: January 30, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy

NCT ID: NCT03400150 Completed - Prostate Cancer Clinical Trials

ProSpaceā„¢ Balloon System Pivotal Study BP-007

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

The ProSpaceā„¢ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the ProSpace System to reduce the radiation dose delivered to the anterior rectum. ProSpace is a balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

NCT ID: NCT03398148 Completed - Clinical trials for Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: March 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

NCT ID: NCT03398135 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Start date: August 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.