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NCT ID: NCT04025749 Completed - Cerebral Palsy Clinical Trials

Cognitive Training Cerebral Palsy

ETCONNECT
Start date: November 13, 2017
Phase: N/A
Study type: Interventional

This study aims to conduct a single-blind randomized controlled trial with sixty children with Cerebral Palsy (CP) to explore if a home-based computerized multi-modal executive training is effective improving infants' executive functions (EF), as the primary outcome. As secondary outcomes, it will be tested if the intervention exerts a positive effect on other cognitive functions, social relationships, and quality of life (QOL) in children with CP. It is expected to observe changes in brain structure and functioning associated to clinical improvements. The primary hypothesis to be tested is that a computerized multi-modal cognitive training will be more effective at improving EF than usual care alone. Secondary hypotheses are that the computerized therapy will be more effective than usual care alone at improving specific cognitive functions such as visuoperception, memory, social relationships and QOL. In addition, we also hypothesize there will be changes on brain structure and function. We further hypothesise that these changes will be maintained over time (9 months). Finally, sociodemographic and clinical factors are expected to be related with the level of efficacy of the computerized multi-modal cognitive training.

NCT ID: NCT04025710 Completed - Syncope Clinical Trials

Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

Start date: October 17, 2019
Phase: N/A
Study type: Interventional

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.

NCT ID: NCT04024410 Completed - Surgery Clinical Trials

Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery

OPTIPRONE
Start date: June 3, 2019
Phase:
Study type: Observational

Background: There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position. Hypothesis: In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position. Aims: To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery. To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure. Methods: Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.

NCT ID: NCT04024371 Completed - Depression Clinical Trials

Validating Reward-related Biomarkers (RTOC)

RTOC
Start date: September 16, 2019
Phase:
Study type: Observational

Deficits or abnormalities in reward processing are present in a number of psychiatric disorders. The overarching objective of the study is to conduct initial validation work towards optimising three experimental tasks - which have previously been shown to be sensitive to reward processing deficits - for future use in clinical trials. This initial validation work has the primary objective to uncover group differences in task outcome measures between healthy control participants, participants with Major Depressive Disorder (MDD) and participants with schizophrenia (SZ) using statistical analyses. This may provide some indications for the use of these tasks as clinically-relevant biomarkers. Primary aims include: (i) comparing the investigator's endpoint means and distributions to those in previously published data; (ii) replication of previously-reported differences between MDD/SZ vs. healthy control participants, and, (iii) exploring the relationship between task endpoints and subjective participant- and clinician-rated report of reward-related constructs (e.g. anhedonia, negative symptoms).

NCT ID: NCT04024319 Completed - Pain, Postoperative Clinical Trials

Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty (GenTKR)

GenTKR
Start date: May 28, 2018
Phase:
Study type: Observational

Knee Osteoarthritis affects one third of the population over 65 years old. Total knee arthroplasty (TKA) has become one of the most frequent surgical procedures in the world. During the last years it went from being a long hospital stay surgery to a fast track procedure. Currently models employ high volume local infiltration techniques (LIA). The genicular nerve block (GNB) appears as alternative in this patients. The objective of this study is to evaluate the analgesic results of genicular nerve block after TKA in a small cohort of patients. 35 patients scheduled for TKA underwent to GNB were included. Pain measurement.

NCT ID: NCT04022122 Completed - Heart Failure Clinical Trials

Impact of Socio Economic Limitations on Health Outcomes in Patients With Recent Admission for Heart Failure

SELENE
Start date: July 15, 2019
Phase:
Study type: Observational [Patient Registry]

To assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for crhonic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of CHF patients and to study the associations between socio-economic level and other psychosocial aspects (secondary objective).

NCT ID: NCT04022070 Completed - Fasciitis, Plantar Clinical Trials

The Effect of Dynamic Tape ® on Plantar Fascitis

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

The Dynamic Tape ® (DT) is a new Tape (2009). Dynamic tape ® is a visco-elastic nylon tape material , greater than 200% elastic has manufactured in Asia. The material and adhesive arefast drying and breathable meaning that the tape, if it is correctly applied may stay on for up to 5 days, bearingin mind that if any discomfort, itching, burning, stinging orirritation is felt immediate removal is strongly advised. Usually tapes are applied in plantar fasciitis to improve the symptoms. The fasciitis plantar is an pain that sometimes incapacitates the physical activity of the patients.

NCT ID: NCT04021290 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)

Start date: November 11, 2019
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.

NCT ID: NCT04020341 Completed - Clinical trials for Urinary Tract Infections

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

Start date: October 17, 2019
Phase: Phase 3
Study type: Interventional

The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

NCT ID: NCT04019873 Completed - HIV Infections Clinical Trials

'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

Start date: November 18, 2019
Phase:
Study type: Observational

Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.