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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: 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: NCT03391258 Completed - Bone Regeneration Clinical Trials

Guided Bone Regeneration With L-PRF in the Atrophic Maxilla - The GLAM Technique

Start date: January 2015
Phase: N/A
Study type: Interventional

16 patients with severe resorbed maxillae referred to Implantology Institute® will be submitted to full arch surgery, with simultaneous implant placement and regeneration in the aesthetic zone, with the GLAM technique. Informed consents and local ethical committee clearance will be obtained. Pre, post and 12 months' follow-up CBCT scans will be performed and 2 independent, calibrated operators will analyze the CBCT scans and mean bone values calculated. The distance from the nasopalatine canal to the center of each implant will be determined (4 different locations per patient, corresponding to implants 14; 11; 21; 24) and it will be the reference to other CBCTs. Implant length will be measured, from the neck (site 1) to the top and then a middle point will be assessed (site 2). Post-Surgical Volume (mm) will be determined from the most palatal point of cortical bone until the most buccal regenerated bone in each CBCT. Regenerated bone gain (mm) at post-op and at 1-year CBCTs will be calculated by the difference between pre and post-op or pre-op and 1 year CBCT measures, respectively. Regenerated Bone stability (%), defined as the percentage of regenerated bone at 12 months, will be calculated as the comparison between CBCT immediately after surgery and the CBCT at 12 months. Results will be presented as mean, with 95% CI.

NCT ID: NCT03390478 Completed - Clinical trials for Mild Cognitive Impairment

Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products

MIND&GAIT
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

A strategy involving 6 partners was planned, targeting the components of education, innovation, and practice-based research with knowledge transfer into clinical practice.The project MIND&GAIT aims to promote independent living in frail older people through the development of innovative initiatives and systems to improve cognition and gait ability. A structured and integrated Combined Intervention (CI) will be developed, composed by: cognitive stimulation program, an animal-assisted therapy program, a physical activity program. Moreover, an auto-blocking mechanism for rolling walkers will be developed and implemented in this study. The results of the study and all the material that was used, will be disseminated in a web platform.

NCT ID: NCT03385564 Completed - Lupus Nephritis Clinical Trials

An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

Start date: January 9, 2018
Phase: Phase 2
Study type: Interventional

The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.

NCT ID: NCT03378531 Completed - Hyperargininemia Clinical Trials

A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency

AEB1102
Start date: December 7, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.