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NCT ID: NCT03855137 Completed - Chronic Migraine Clinical Trials

Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

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

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

NCT ID: NCT03854968 Completed - Clinical trials for Mechanical Ventilation

Quality Control of Home Mechanical Ventilators

Start date: December 15, 2017
Phase: N/A
Study type: Interventional

A multicentre quality control survey of home mechanical ventilation in patients. The prescribed ventilation settings, the settings of the ventilator control panel and the actual performance of the ventilator will be tested.

NCT ID: NCT03854305 Completed - Crohn's Disease Clinical Trials

Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease

PRINCE
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease

NCT ID: NCT03853733 Completed - Rectal Cancer Clinical Trials

Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer

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

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

NCT ID: NCT03853109 Completed - Clinical trials for Advanced Solid Tumors

AMG 404 in Patients With Advanced Solid Tumors

Start date: March 5, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.

NCT ID: NCT03851926 Completed - Prostate Cancer Clinical Trials

Hypofractionated Radiotherapy for Prostate Cancer

HRT20
Start date: October 5, 2016
Phase:
Study type: Observational

Radiotherapy is a standard definitive treatment for men with localized prostate cancer. Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects. This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0

NCT ID: NCT03851653 Completed - Clinical trials for Obstructive Sleep Apnea

Lifestyle Intervention for OSA in Adults

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

Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.

NCT ID: NCT03850756 Completed - Kidney Injury Clinical Trials

Early Diagnosis of Kidney Damage Associated With Tobacco Use

Start date: March 4, 2019
Phase:
Study type: Observational

Tobacco consumption is associated with the appearance of several pathologies, the best known are Chronic Obstructive Pulmonary Disease, several types of cancer and cardiovascular diseases. However, the association between tobacco and kidney damage is not well defined. Some studies suggest that smoking favors progression to chronic kidney disease (CKD). CKD does not have pharmacological treatment and the only clinical strategies useful so far are dialysis or kidney transplantation. Therefore, knowing if tobacco is involved in this disease is a very relevant fact, since it is a modifiable factor. Of all the risk factors associated with the onset and progression of kidney disease is the only one that can be avoid or eliminated. Therefore quitting smoking could help reduce the incidence of this pathology. In this project, 3 main objectives were proposed: 1. First: to study the tobacco-CKD association in a more exhaustive way. In a population group (patients who attend a primary care center) the renal function of smokers will be evaluated, comparing it with that of non-smokers with similar characteristics (age, sex, etc). In addition, the presence of certain pathologies that can affect the kidney (diabetes mellitus, hypertension and / or frequent consumption of certain medications) will be taken into account. To evaluate the renal functionality, the markers commonly used in the clinic and other more novel ones will be used (urinary biomarkers of early kidney damage). 2. Second: to assess whether smoking patients will be more likely to suffer kidney damage in the future. This will be done by monitoring the patients mentioned above, for two years. During this time, a group of novel markers (urinary biomarkers of predisposition to kidney damage) that in previous studies have detected susceptibility to kidney damage will be evaluated. It will be determined which one or more of these markers are capable of predicting at time 0 (when the first sample of the patient is taken) the subsequent appearance of renal damage. 3. Third: to study whether stopping smoking reduces the risk of developing CKD. It will be evaluated whether stopping smoking reduces the susceptibility to kidney damage by using the biomarkers mentioned above.

NCT ID: NCT03849755 Completed - Clinical trials for Diabetes Mellitus, Type 1

Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.

PEPPER
Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Patient Empowerment through Predictive PERsonalised Decision Support (PEPPER) is an European Union (EU) funded research project to develop a personalised clinical decision support system for Type 1 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an artificial intelligence methodology that adapts to new situations according to past experience. The PEPPER system also incorporates a safety module that promotes safety by providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and fault detection. The principal research objective is to demonstrate safety, feasibility and usability of the PEPPER system compared to a standard bolus calculator.

NCT ID: NCT03848858 Completed - PTSD Clinical Trials

Efficacy of EMDR Therapy, as Compared to Treatment as Usual, in Reducing Clinical Symptoms in People With HIV

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

People living with HIV may suffer HIV-related psychological trauma. Studies also show that this group is vulnerable to non-HIV-related trauma. Trauma can increase vulnerability to stress and reducing the ability to cope. It can have a negative impact on treatment adherence, treatment outcomes, functioning and health-related quality of life. However, despite evidence showing psychological trauma can contribute to poor outcomes in HIV, little research has been carried out to assess whether psychological trauma-focused therapy can help people living with HIV. A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing (EMDR) therapy. This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder, with many studies showing this treatment is safe and effective for this disorder. However, it has not to our knowledge been specifically tested in the population of people living with HIV. This project will test whether EMDR therapy, in addition to the standard medical treatment received at the Infectious Diseases Unit, is more effective than standard medical treatment alone in reducing psychological trauma, improving health-related quality of life and improving HIV outcomes in people recently diagnosed with HIV. To test this, the investigators will recruit 40 people who have received a diagnosis of HIV within the last month. 20 will be offered the possibility to receive EMDR treatment for one hour weekly for up to 6 months, in addition to the standard medical treatment, while the other 20 will be offered only the standard medical treatment. The hypotheses of the present study are that the participants who receive EMDR therapy on top of their standard medical treatment will show a reduction in psychological trauma and related symptoms such as anxiety, depression and global distress, as compared to those who did not. The investigators also predict that the EMDR group will show improved functioning and health-related quality of life. The final hypotheses are that the EMDR group will show improved treatment adherence and HIV outcomes. If this study shows that a psychological trauma-focused therapy can help people adjust to a recent HIV diagnosis and have better outcomes, this will have important implications for improving care for people living with HIV.