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NCT ID: NCT04684238 Completed - Sedation Clinical Trials

Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old

IsoCOMFORT
Start date: January 14, 2021
Phase: Phase 3
Study type: Interventional

This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.

NCT ID: NCT04683783 Completed - Rectal Cancer Clinical Trials

National Registry of Liver First Approach

RENACI
Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. The liver first approach was described by Mentha for patients with asymptomatic rectal tumors with with initially unresectable or borderline resectable liver metastases. There is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy.

NCT ID: NCT04683263 Completed - Chronic Pain Clinical Trials

Immediate and Mid-term Effect of a Natural Topical Product in Patients With Musculoskeletal Pain

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

Musculoskeletal pain is a common affection due to ageing, sedentarism and intense exercise practice causing acute and chronic injuries. The main objective of this trial is to prove efficacy of a natural topical composition containing Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and menthol in pain management in adults with acute or chronic pain. This randomized, double-blinded and placebo-controlled trial will include 200 patients with musculoskeletal pain, 100 in the intervention group receiving the topical formula and 100 in the placebo group, who will receive a similar formula without active ingredients. The products will be applied topically twice daily for 14 days in areas with moderate or severe pain. The study objectives are immediate and long-term pain alleviation, stiffness perception joint mobility, and general recovery perception.

NCT ID: NCT04682639 Completed - Clinical trials for Eosinophilic Esophagitis

A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

VOYAGE
Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.

NCT ID: NCT04682496 Completed - Patellar Tendinitis Clinical Trials

Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

Start date: December 18, 2020
Phase: N/A
Study type: Interventional

In the sports field, patellar tendinopathy is, as a pathology, one of the main concerns for athletes, both because of its incidence and because of the difficulty involved in their recovery. At the ultrasound level, tendinopathies can be divided, depending on the presence or absence of an intratendon Doppler signal, into hypervascular or hypovascular tendinopathy. Its classification is, today and clinically speaking, merely qualitative through the observation of the explorer. The ultrasound evaluation is carried out through a probe that is placed on the patient's skin, the procedure to be followed to obtain a vascular image is merely operator-dependent, that is, the position of the probe, the pressure exerted on the skin or even ultrasound optimization parameters can drastically modify the results. Due to high pressure on the probe, the intratendon Doppler signal may be diminished in the quantitative variables of area, number of signals, pixel intensity, perimeter, solidity, perfusion index, circularity, major and minor diameter. From a certain pressure on the probe, the intratendon Doppler signal can be drastically altered. This study will try to evaluate the influence of the pressure exerted by the examiner with the probe on the quantitative variables of the intratendon Doppler signal in patellar tendinopathy. To carry out the study, a single group with patellar tendinopathy will be established. Ultrasound evaluations with Doppler mode will be performed on the tendon using different probe pressures, monitoring the applied force and recording the images obtained for later analysis.

NCT ID: NCT04682041 Completed - Covid19 Clinical Trials

Evaluating the Impact of EnteraGam In People With COVID-19

PICNIC
Start date: December 22, 2020
Phase: N/A
Study type: Interventional

Background: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), emerged as a potentially life-threatening disease in Wuhan, China, at the end of 2019. Since then, it has spread to almost 200 countries and infection rates are rapidly accelerating. Overactivation of T cells resulting in immune dysfunction, dysfunction of the renin angiotensin system, and antibody-dependent enhancement are thought to contribute to the cytokine storm that results in acute respiratory distress syndrome (ARDS), culminating in death. In addition to causing respiratory symptoms, SARS-CoV-2 can cause diarrhea and has been isolated from the stool. SARS-CoV-2 binds to Angiotensin-converting enzyme 2 (ACE2) on lung alveolar type 2 cells, but ACE2 is also expressed in the absorptive enterocytes from the ileum and colon. The diarrhea may be caused by increased intestinal permeability due to binding of these receptors by the SARS-CoV-2. Thus, an intervention to attenuate this cytokine storm may improve clinical outcomes in people with COVID-19. One such intervention is oral administration of serum bovine immunoglobulins, which decreases interleukin-6 (IL-6) levels safely with minimal side effects. Animal and human clinical studies have shown dietary supplementation with oral immunoglobulins improves mucosal immunity, specifically respiratory/pulmonary and GI mucosa, and decreases systemic inflammation, reducing the symptoms and severity of pulmonary inflammation and viral infections. Hypothesis: Dietary supplementation with EnteraGam® will decrease IL-6 levels and prevent disease progression in SARS-CoV-2 infected individuals. Objectives: To evaluate the effectiveness of the oral nutritional therapy EnteraGam® (serum-derived bovine immunoglobulin/protein isolate) to prevent disease progression of COVID-19 and to decrease IL-6 levels as compared to standard of care in subjects with COVID-19. Methods: Randomized open-label clinical study evaluating the effectiveness of EnteraGam® 10.0 g BID (every 12 hours) added to standard of care, as compared to standard of care alone, in subjects with COVID-19.

NCT ID: NCT04681976 Completed - Aging Well Clinical Trials

Telematic Dance Intervention on Quality of Life of Older

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

The aim of this study is to analyse the effectiveness of a telematic dance intervention on the quality of life of older people. This project is a controlled, randomized clinical trial. 54 people (Intervention Group, n=27; Control Group, n=27) between the ages of 60-80 will participate in the study. Intervention Group participants will perform a 3-month telematic dance program based on choreographic work. The participants shall be measured 3 times, at baseline, post-intervention, and at 6-month post-intervention follow-up. Aside from the quality of life, variables of balance, risk of falling, number of falls, level of physical activity, mood, functionality, comorbidity, and quadriceps strength will also be measured.

NCT ID: NCT04681547 Completed - Pain Clinical Trials

Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

PGENECA
Start date: December 15, 2020
Phase: Phase 4
Study type: Interventional

The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia (LIA). It is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee, reducing the total dose of local anesthetic and adrenaline very markedly.

NCT ID: NCT04680559 Completed - Clinical trials for Mindfulness, Compassion

Mindfulness Training for Psychotherapeutic Care

EMAP
Start date: September 29, 2018
Phase: N/A
Study type: Interventional

It has been shown that mindfulness-based interventions (MBI) applied to psychotherapists improve their empathy and increase the therapeutic alliance. It is expected that these improvements may beneficially affect the results of psychotherapy. However, new studies are needed to examine whether an MBI can have an effect on the healthy evolution of these professionals' patients. The objective of this project is to analyze the influence of a mindfulness and compassion based intervention (MCBI) applied to psychotherapists, on the empathy perceived by their patients, the therapeutic alliance and their symptomatology. This study is a randomized clinical trial of an intervention based on MBSR and adapted to the population of psychotherapists, including in the last two sessions the practice of compassion, called Mindfulness and Compassion Based Intervention (MCBI). The subjects (n = 63) were randomly assigned to MCBI (n = 33) or to a Waiting List group in which they fill in a self-record of their own feelings, thoughts, etc. in therapy for 8 weeks (n = 30). Participants in the MCBI intervention condition were asked to meet weekly during a two-hour session for two months. Pre / post-intervention and five-month evaluations were performed as a follow-up. Mindfulness measures (FFMQ) will be taken for the evaluation of psychotherapists, Self-compassion (SCS-SF), negative symptomatology (DASS-21), empathy (EUS-T, TECA), personal therapist style (EPT-C) and mindfulness instructional style (MIQ). For the evaluation of patients, measures of mindfulness (FFMQ), self-compassion (SCS-SF) will be taken - to try to control without these skills they can be vicariously modified without being directly trained-, subjective well-being (PHI), psychological well-being (BSI), therapeutic alliance (WATOCI, ENAT) and perceived empathy (EUS-P).

NCT ID: NCT04678856 Completed - Sinusitis Clinical Trials

Dupilumab in CRSsNP

Liberty CRSsNP
Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: - To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo - To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo - To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo - Assessment of immunogenicity to dupilumab over time compared to placebo