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NCT ID: NCT03961620 Completed - Hypothermia Clinical Trials

Study on the Incidence of Perioperative Hypothermia at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell

PREVINQ-WARM
Start date: July 9, 2019
Phase:
Study type: Observational

The study TAULÍ-PREVINQ-WARM will assess the rate of perioperative hypothermia in patients submitted to major surgical procedures at the operating room main area (and at the ambulatory surgery building for ophthalmologic major procedures) of the Parc Taulí, Hospital Universitari, Sabadell, Barcelona.

NCT ID: NCT03961399 Completed - Heart Failure Clinical Trials

Study to Evaluate the Superior Efficacy of Cardiac Resynchronization (SyncAVTM) Using the SyncAVTM Algorithm

CRUSTY
Start date: December 18, 2018
Phase: N/A
Study type: Interventional

Heart Failure (HF) is a cardiovascular disease secondary to a structural and / or functional alteration of the heart that prevents its correct function. The Cardiac resynchronization therapy (CRT) aims to restore atrioventricular, inter and intraventricular synchrony in patients with systolic HF and wide depolarization of the ventricles (QRS). Although CRT has been shown to be effective, the rate of non-responders is high (30-50%). One of the proposed reasons for the lack of response to the CRT is the lack of intrinsic conduction, since most of the time CRT is administered using biventricular stimulation (BiV). One of the limitations to achieve ventricular fusion are the dynamic physiological variations of the auriculo-ventricular (AV) interval. The SyncAVTM algorithm is a new dynamic algorithm that manages to adjust the AV intervals outside the clinic. The design of the present clinical study is post-marketing, prospective, multicenter, randomized and blind for the patient and the central echocardiography laboratory. The objective of this study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with conventional BiV stimulation in the population for which its use is foreseen. The data will be collected in at least the Selection / Baseline Visit and in the Visit of Follow-up at 6 Months. The study population are subjects to whom an Abbott Medical CRT has been implanted with SyncAVTM® Stimulation function that go to the participating sites in the study. The main objective of the study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with BiV stimulation conventional in terms of the rate of responders. The main endpoint is the determination of significant differences between conventional BiV stimulation and ventricular stimulation with fusion using the SyncAVTM algorithm in terms of the percentage of patients responding to CRT therapy with echocardiogram. The duration of the clinical study is estimated at 24 months with a recruitment period of 18 months and a patient follow-up of 6 months. The number of subjects that is planned to be recruited is 176. The inclusion will be competitive and there is no inclusion number determined per site.

NCT ID: NCT03961204 Completed - Clinical trials for Multiple Sclerosis (MS)

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Start date: August 15, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

NCT ID: NCT03961126 Completed - Clinical trials for Vulvar Lichen Sclerosus

Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.

Start date: September 6, 2017
Phase: Phase 2
Study type: Interventional

LIQUENIA clinical trial is a phase II, controlled, prospective and unicentric study to assess vulvar lichen sclerosus (VLS) treatment using adipose tissue associated with autologous platelet-rich plasma (PRP) coming from the inner side of the patients' thighs, which aims to restore the structure and elasticity of the affected vulvar subunits, and to improve vulvar subunits lesions and symptoms, therefore, patients' quality of life from the early phases of the treatment.

NCT ID: NCT03961022 Completed - Muscle Soreness Clinical Trials

Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice

Start date: October 22, 2018
Phase: Phase 2
Study type: Interventional

The study will assess the recovery and performance of young athletes suffering from muscle damage induced by physical exercise. Model by comparing the safety and efficacy of ReWin(d) supplemention during 4 weeks to placebo over 72 hours post exercice.

NCT ID: NCT03960723 Completed - Informed Consent Clinical Trials

Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Start date: May 9, 2019
Phase:
Study type: Observational

The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess. The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.

NCT ID: NCT03960580 Completed - Clinical trials for Chronic Rhinosinusitis

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

Start date: June 6, 2019
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps

NCT ID: NCT03960086 Completed - Sever's Disease Clinical Trials

Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis

Start date: June 12, 2019
Phase: N/A
Study type: Interventional

The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis. It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.

NCT ID: NCT03959657 Completed - Hip Fractures Clinical Trials

Analysis of a Population in Extreme Age of Life With a Hip Fracture

Start date: April 24, 2017
Phase:
Study type: Observational

Observational retrospective study of pacients over 95 years admitted in traumatology ward with a osteoporotic hip fracture

NCT ID: NCT03959631 Completed - Clinical trials for Ischemic Heart Disease Chronic

Effectiveness and Cost-effectiveness of a VCoP to Empowerment of Patients With Ischaemic Heart Disease in PHC: Cluster-RCT

Empodera-dos
Start date: January 11, 2021
Phase: N/A
Study type: Interventional

Objective: to evaluate the effectiveness and estimate the costs of a Virtual Community of Practice in the improvement of the activation of patients with Ischemic Heart Disease in Primary Care . Methods: Design: pragmatic randomized controlled multicentric trial. Setting: health centres belonging to the Autonomous Communities of Catalonia, Madrid and the Canary Islands. Population: 246 patients with Ischemic Heart Disease in Primary Care. Randomization: randomization will be central and automatically performed by the online "e-mpodera" platform and the assigned group will be communicated to the patient once he or she has entered the platform and completed baseline assessment. Intervention: the intervention group will be offered participation for 6 months in a Virtual Community of Practice based on a web 2.0 platform in which there is interaction with other patients and with a multidisciplinary team of professionals. The intervention will be co-designed with a group of patients and a group of primary and specialized care professionals. The control group will receive usual care. Measurements: the main variable will be measured using the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary variables: sociodemographic and clinical variables of the patients; knowledge test (questionnaire of risk cardiovascular factories , attitudes (Self-efficacy Managing Chronic Disease Scale ), adherence to Mediterranean diet (Mediterranean Diet), level of physical activity (International Physical Activity Questionnaire), medication adherence (Adherence Refill and Medication Scale (ARMS-e), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L); variables related to the use of health resources; variables related to the use of the Virtual Community of Practice . Data will be collected from self-reported questionnaires and the electronic medical records. Analysis: a linear regression model of mixed effects will be estimated to estimate the effect of participating in the Virtual Community of Practice. In addition, subgroup analyses will be carried out and indicators of the functioning of the Virtual Community of Practice will be measured through techniques of Social Network Analysis and Control Charts. There will be an economic evaluation of the Virtual Community of Practice from the perspective of the National Health System and from the social perspective.