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NCT ID: NCT03877172 Not yet recruiting - Respiratory Failure Clinical Trials

High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study

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

The goal of this study is to evaluate the role that high-flow nasal cannulas (HFNC) have on respiratory drive, work of breathing and neuromuscular efficiency after lung resection surgery. The main question the investigators aim to answer is whether HFNC decrease respiratory drive by at least 15% in these patients, assessed by a special diaphragmatic electromyography (EMG) device (NAVA catheter). In order, to perform this study, the investigators will perform a physiological study in 40 patients. These patients will be assessed in the immediate postoperative period and HFNC will be compared to conventional face-mask therapy.

NCT ID: NCT03876522 Recruiting - Lafora Disease Clinical Trials

Natural History and Functional Status Study of Patients With Lafora Disease

Start date: January 10, 2019
Phase:
Study type: Observational

A natural history and functional status study to characterize the clinical disease course in Lafora disease patients using standardized, quantitative evaluations and to identify useful biomarkers and clinical outcome measures for use in future Lafora treatment studies.

NCT ID: NCT03876119 Recruiting - Stroke, Acute Clinical Trials

Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy

CHOICE
Start date: December 5, 2018
Phase: Phase 2
Study type: Interventional

Multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with mechanical thrombectomy (MT), in which two therapies are compared: rt-PA or placebo. Allocation at each center will account for 1 stratum: use of alteplase (yes vs. no) before MT. Subjects will be followed up to 90 days post-randomization.

NCT ID: NCT03875261 Not yet recruiting - Endometriosis Clinical Trials

Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis

EdomTHC
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.

NCT ID: NCT03875079 Not yet recruiting - Metastatic Melanoma Clinical Trials

A Phase IB Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant Targeting Fibroblast Activation Protein-Α, In Combination With Pembrolizumab (Anti-Pd-1), In Participants With Previously Untreated Advanced And/Or Metastatic Melanoma

Start date: April 10, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 2 parts: a safety run-in (Part I) and an expansion (Part II). Part II will start once all participants in Part I have completed the observation period.

NCT ID: NCT03874624 Recruiting - Atrial Function Clinical Trials

Normal Values for Myocardial Left Atrial Strain

Start date: February 22, 2019
Phase:
Study type: Observational

Transversal retrospective and unicentric study. The investigators sought to determine the normal values for two-dimensional myocardial left atrial strain for the cardiology ultrasound system available in their centre (Philips EPIQ ultrasound machine and 10.8.5 QLAB cardiac analysis software). Studies performed in their department which meet the criteria for an adequate strain analysis will be retrospectively reviewed.

NCT ID: NCT03873519 Recruiting - Breast Cancer Clinical Trials

Acute Effect of Chromatic Environment During Chemotherapy

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

The primary objective is to examine the acute effect of color, room orientation (affecting amount of luminosity) on perceived health status and stress levels in oncologic patients during chemotherapy sessions at outpatient clinic. The secondary objectives will be to study the effect on vital signs (body temperature, heart rate, systolic blood pressure). Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South) for each session. For the next session, patients will be assigned a new condition. Assignment of sequences will be randomized for each patient. 20 patients will be randomly assigned to one of the four groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be treated per standard of care.

NCT ID: NCT03872726 Recruiting - Ulcerative Colitis Clinical Trials

Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease

IBD-OWDI
Start date: March 1, 2019
Phase:
Study type: Observational [Patient Registry]

Background theme Crohn's disease (CD) and ulcerative colitis (UC) are chronic diseases that alternate flares of active inflammation with periods of clinical remission. The working capacity of patients may be affected both by disease activity and by the aggressive treatment or surgical intervention required for the management of the disease and its complications. Work disability and impairment are especially important in patients with inflammatory bowel disease (IBD) because the disease affects young individuals who are generally employed and fully active. Although there are several indexes in the literature that assess the degree of work disability due to IBD, all have a high degree of subjectivity, so none can be used to request disability pensions. Experience of the research group on the subject Our group has developed a line of research on work disability associated with IBD. Initially the investigators have studied the parameters that condition the granting of disability pensions of Spanish courts. Subsequently, a population study of the prevalence of work disability in Spain has been carried out. Finally, the investigators develop and validated a disability index for CD (published in its extensive and reduced form) and for UC (currently under review). Hypothesis The IBD generates a work disability that can be measured objectively. Establishing the parameters related to disability is essential to promote equity in administrative and judicial decisions related to the granting of disability pensions to patients with IBD. Objective Development and validation of an objective index to measure the degree of disability in IBD. Material and methods: Study 1: A self-reported and objective questionnaire of disability will be developed based on the data of the population survey already carried out by our group. Patients from a previous study (n 293) will be included. The relationship of different objective variables and disability outcomes will be analyzed with a univariate and a subsequent multivariate analysis. Alternative work disability scores will be developed. Study 2: for the validation of the questionnaire a new online interview will be performed, patients from patients' assocations will be asked to participate. Data Collection: patients will answer a online survey administered with the SurveyMonkey © platform. Participant will answer questions about demographics, disease activity, treatment and complications and data regarding disability. Patients will also complete the SCDWDQ (Short Crohn's Disease Work Disability Questionnaire), Work Productivity and Activity Index (WPAI), IBDQ-9, the EuroQol and IBD-DI (IBD disability index). Statistical analysis: psychometric properties of the index will be evaluated: 1. Convergent validity: the Spearman correlation will be used to correlate the objective disability score with IBD-DI and SCDWDQ. 2. Discriminant validity: it will be measured by the t-test among patients with different degrees of disability (inactive-active, hospitalization-no hospitalization, surgery-no surgery).

NCT ID: NCT03872258 Not yet recruiting - Healthy Clinical Trials

Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women

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

This is a randomized clinical trial aimed at postmenopausal women aged 45 to 70 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of an intensive intervention in the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and sedentary women.

NCT ID: NCT03872167 Recruiting - Clinical trials for Hypercapnic Respiratory Failure

Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.

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

To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.