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NCT ID: NCT03232879 Completed - Clinical trials for Autonomic Nervous System

Combining Motor Imagery With Action Observation Does Not Lead to a Greater Autonomic Response Than Motor Imagery Alone During Simple and Functional Movements: a Randomized Controlled Trial.

Start date: January 30, 2017
Phase: N/A
Study type: Interventional

The main objective of this study was to compare the activation of the Sympathetic Nervous System in a program that combined Motor Imagery with Action Observation, in contrast to an isolated Motor Imagery program on the one hand in asymptomatic subjects and in the other hand in patients with chronic low back pain.

NCT ID: NCT03232645 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation

LOCALIZE
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

NCT ID: NCT03232073 Completed - Multiple Sclerosis Clinical Trials

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

OPTIMUM-LT
Start date: July 5, 2017
Phase: Phase 3
Study type: Interventional

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

NCT ID: NCT03231787 Completed - Femur Fracture Clinical Trials

Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery

AFFEcT
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

National, randomized, open, parallel, multicenter clinical trial of two comparison groups that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the surgery time in antiaggregated patients with proximal femur fracture. The experimental group will undergo surgery as soon as platelet aggregability, according to the PLATELETWORKS® method is correct within 24-48 hours. The control group will undergo surgery according to the usual practice of the center taking into account the safety time of the antiplatelet agent.

NCT ID: NCT03231657 Completed - Preeclampsia Clinical Trials

Randomizated Open-label Control Trial to Evaluate if the Incorporation of sFlt1/PlGF Ratio in the Diagnosis and Classification of PE Improves Maternal and Perinatal Outcomes in Women With the Suspicion of the Disease

EuroPE
Start date: February 6, 2018
Phase: N/A
Study type: Interventional

Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality worldwide. The morbidity and mortality of this condition arises from two main causes: 1) the lack of specific and sensible methods for its diagnosis and prognosis, 2) and the fact that the course of the disease is often unpredictability at its presentation and speed of progression. The majority of deaths are undoubtedly avoidable and are due to a substandard care. Nowadays it's known that preeclampsia is a placental disorder that is characterized by an unbalance of angiogenic and antiangiogenic factors. It has been recently proven that the ratio of sFlt-1 to PlGF in women who presented with a clinical suspicion of preeclampsia is useful distinguishing between women in whom preeclampsia would develop and those in whom it would not. A low ratio also predicted the absence of fetal adverse outcomes in the same time frame. In addition this ratio demonstrated to be useful to discriminate among patients that would developed maternal or fetal adverse outcome. Correct identification and diagnosis of women at risk could potentially prevent all these adverse outcomes thus, clinical experience suggests that early detection and monitoring are beneficial. EuroPE aims to provide evidence that the re-definition of pre-eclampsia as an entity caused by a placental unbalance of angiogenic and anti-angiogenic factors and its incorporation in the diagnosis and classification of the disease would improve maternal and neonatal health. This will be an open, multicentre, international, randomised controlled trial with an intention-to -treat analysis. The study is pragmatic: it will be undertaken to reflect real clinical practice rather than the very tightly controlled circumstances of explanatory trials. The main objective of this study is to determine the effects of the use of the ratio as a diagnostic tool in the definition and classification of PE, as compared with its usual definition, in triage and delivery decisions and to see whether this new approach is able to improve maternal and perinatal outcomes.

NCT ID: NCT03230955 Completed - Smoking Cessation Clinical Trials

Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

QUITMENTAL
Start date: May 2, 2017
Phase: N/A
Study type: Interventional

Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge. To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.

NCT ID: NCT03230318 Completed - Clinical trials for Intrahepatic Cholangiocarcinoma

Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

FIDES-01
Start date: September 28, 2017
Phase: Phase 2
Study type: Interventional

This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.

NCT ID: NCT03227952 Completed - Fibromyalgia Clinical Trials

Sensory Stimulation in Fibromyalgia

Start date: September 4, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.

NCT ID: NCT03227211 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive, Severe Early-Onset

COPD Readmissions Prediction- ReCOPD Project

ReCOPD
Start date: October 1, 2016
Phase:
Study type: Observational

To develop predictive models for short-term readmission (60 days) and medium term (one year) for patients with an exacerbation of COPD (eCOPD) which are admitted to any of the participant hospitals. To identify factors contributing to readmission from the time of discharge from the index admission to the studied readmission time. Methodology. Design: Prospective cohort study with a nested case control study, with follow up to one year. Patients: 1500 patients admitted over a year and a half in any of the 9 participant hospitals by an eCOPD. Methods: During admission, background information on patient situation prior to admission, data of the ED during admission, and discharge planning, will be collected from medical history. The investigators will also survey patients (generic and specific health-related quality life -HRQoL- dependence, social support, presence of fragility). All patients will be followed to determining whether any readmission until 60 and up to one year of discharge from the index admission occurs. Patients readmitted at the first 60 days after discharge will be surveyed on a number of possible causes of readmission (continuity of care, medication, complications, individual and social factors). A one to one control group will be established to compare different factors studied in the case group (readmission). Statistical analysis: predictive models will be developed from the derivation sample, and validated in a validation sample. Also, the factors evaluated in the case-control study will be compared using appropriate test for paired samples.

NCT ID: NCT03226392 Completed - Asthma Clinical Trials

Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

Start date: October 31, 2017
Phase: Phase 3
Study type: Interventional

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.