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NCT ID: NCT03928366 Completed - Sedative Overdose Clinical Trials

Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses

Start date: June 13, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Background: The mechanisms of action of intravenous anesthetics are unclear and the current monitors have limitations. This signifies difficulties when assessing the correct dosage due to the considerable inter-individual variability of the patients, particularly in the elderly or seriously ill. It is necessary to customize the administration of anesthetics as underdosage can lead to the patient awareness during aggressive procedures, and over-dosage can cause serious complications and even augment mortality. Objective: To design a new monitoring system of the levels of consciousness and analgesia in anesthetized subjects which is more accurate than those currently employed. It will be based on the synchronic changes of functional magnetic resonance (fMR) and electroencephalograph (EEG) readings, and clinical responses. Methodology: Thirty healthy volunteers will be given propofol and remifentanil in different combinations, and painful stimuli will be also applied. The principal variable will be fMR images obtained by echo-planar imaging sequences. Real time will be correlated with cortical connectivity maps, EEG parameters (qCON, qNOX), clinical responses, and concentrations of anesthetics measured by pharmacokinetic and pharmacodynamic models (TCI).

NCT ID: NCT03927690 Completed - Clinical trials for Diabetic Macular Edema

Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema

Start date: May 24, 2019
Phase: Phase 2
Study type: Interventional

The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),

NCT ID: NCT03927534 Completed - Clinical trials for Overweight and Obesity

Efficacy of a Mindful-eating Program to Reduce Emotional Eating

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.

NCT ID: NCT03927144 Completed - Episodic Migraine Clinical Trials

Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients

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

The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.

NCT ID: NCT03926611 Completed - Clinical trials for Chronic Spontaneous Urticaria

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Start date: June 6, 2019
Phase: Phase 2
Study type: Interventional

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

NCT ID: NCT03926195 Completed - Clinical trials for Rheumatoid Arthritis

Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis

MANTA-RAy
Start date: May 28, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.

NCT ID: NCT03926169 Completed - Clinical trials for Hidradenitis Suppurativa

A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

DETERMINED 1
Start date: June 3, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.

NCT ID: NCT03926130 Completed - Crohn's Disease Clinical Trials

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

VIVID-1
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

NCT ID: NCT03924089 Completed - Clinical trials for End Stage Renal Disease

Oral Nutritional Supplement on Nutritional and Functional Status, and Biomarkers in Malnourished Hemodialysis Patients.

RENACARE
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

Malnutrition in hemodialysis patients is frequent and it is associated with a reduction in muscular mass, strength, functional capacity and quality of life, with an increment in inflammatory and oxidative markers, and with a dysregulation of circulating miRNAs and its target genes. Animal and human studies have reported that some dietary components (macronutrients, micronutrients and other bioactive substances) might restore these altered features. Thus, we hypothesized that the intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might: - Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life. - Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in malnourished hemodialysis patients. The present study is a randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or individualized diet recommendations, but double-blind to the intake of probiotics. Inclusion criteria comprised adult subjects (>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion and at least one of these caloric malnutrition criteria: a) involuntary weight loss >5% in 3 months or >10% in 6 months; b) serum albumin < 3.5 g/dl or prealbumin <28 mg/dl; c) body mass index (BMI) < 23 kg/m2; d) muscular mass loss >5% in 3 months or >10% in 6 months. The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). A nutritional examination that included anthropometric measurements, handgrip strength measured by a hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA) and a 5 days dietary record; quality of life evaluation by the "12-item short form health survey"; the presence of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale); assessment of functional status by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"; and blood and stool samples will be obtained for each participant in each study visit (except screening visit).

NCT ID: NCT03923985 Completed - Vaginal Flora Clinical Trials

Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora

Start date: March 21, 2019
Phase: N/A
Study type: Interventional

Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora