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NCT ID: NCT03876054 Recruiting - Chronic Pain Clinical Trials

Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

REALITY
Start date: March 13, 2019
Phase:
Study type: Observational

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

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: NCT03872778 Recruiting - Neoplasms Clinical Trials

[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake

NeoRay
Start date: July 24, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this first-in-human (FIH) study of [177Lu]-NeoB is to characterize the safety, tolerability, pharmacokinetics (PK) as well as the distribution and radiation dosimetry, and anti-tumor activity of [177Lu]-NeoB in patients with advanced solid tumors known to overexpress Gastrin-Releasing Peptide Receptor (GRPR) and with [68Ga]-NeoB lesion uptake.

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: NCT03871192 Recruiting - Facet Joint Pain Clinical Trials

Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

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

In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.

NCT ID: NCT03869190 Recruiting - Bladder Cancer Clinical Trials

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

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

A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.

NCT ID: NCT03868280 Recruiting - Femur Fracture Clinical Trials

The FLiP Study, a Pilot Cluster Randomized Trial

FLiP
Start date: October 16, 2020
Phase: N/A
Study type: Interventional

The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of lateral patient positioning versus supine positioning with fracture table use for reamed antegrade intramedullary fixation of femur fractures.

NCT ID: NCT03868046 Recruiting - Cancer Clinical Trials

Autoantibodies in Treatment With Immune Checkpoint Inhibitors (AUTENTIC)

AUTENTIC
Start date: August 25, 2019
Phase:
Study type: Observational

The aim of this study is to assess the effectiveness of a battery of autoantibodies to predict the occurrence of immune-related adverse events (irAEs) in patients with cancer who will be treated with immune checkpoint inhibitors (ICIs) per standard protocol.

NCT ID: NCT03866603 Recruiting - Parkinson´s Disease Clinical Trials

Rostock International Parkinson's Disease Study (ROPAD)

ROPAD
Start date: May 30, 2019
Phase:
Study type: Observational

Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.