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NCT ID: NCT03998956 Not yet recruiting - Atrial Fibrillation Clinical Trials

High-density Mapping-guided bOx Isolation and subsTrate Ablation

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

This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.

NCT ID: NCT04000867 Not yet recruiting - Clinical trials for Diabetic Peripheral Neuropathy

Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)

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

The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN) if used weekly for a month

NCT ID: NCT04001491 Not yet recruiting - Inflammation Clinical Trials

Interest of 18F-FDG Positron Emission Tomography in the Management of Fevers and Inflammatory Syndromes

Start date: August 1, 2019
Phase:
Study type: Observational

Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients. In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients

NCT ID: NCT04003545 Not yet recruiting - Low Back Pain Clinical Trials

Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain

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

Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. This pain is classified as non-specific lumbar pain when its cause is unknown, as well as chronic when it persists for longer than three months with the appearance of disabilities for activities of daily life. Treatments for low back pain are usually pharmacological, focusing on analgesics, muscle relaxants and anti-inflammatories. Although protective factors, such as exercise, healthy diet and functional training may mitigate the evolution of pain, physical disability due to pain and functional loss reduce quality of life. Photobiomodulation (PBM) can be defined as the therapeutic use of light sources to reduce inflammation and relief pain. In this context, the objectives of this study are to develop and evaluate the effectiveness of an application protocol of an LED cluster for the treatment of chronic low back pain in a randomized, double-blind clinical trial that will be conducted in the outpatient facility of Universidade Nove de Julho (Uninove). Patients with chronic nonspecific low back pain, who signs the Informed Consent Form approved by the Uninove Institutional Review Board will be included in the study. Treatment sessions will be performed with a LED cluster three times a week for 4 weeks (totaling 12 sessions) in the lumbar region, and the outcomes will be measured with the following evaluations: VAS - Visual Analog Scale; Roland-Morris Disability Questionnaire (RMDQ); Schöber test; Modified Oswestry Disability Questionnaire and Algometry.

NCT ID: NCT04004858 Not yet recruiting - Prostate Cancer Clinical Trials

Prostate Margin Reduction to Reduce Acute Rectal Toxicity (PROTRACT)

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

The objectives of this study are: 1. Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments 2. Demonstrate in a prospective pilot clinical trial that patients planned and treated with the reduced margin schema will have reduced acute rectal toxicity

NCT ID: NCT04005768 Not yet recruiting - Obesity Clinical Trials

Effect of Hydroxychloroquine Sulphate in Healthy Lean Females

PLAQHV
Start date: August 1, 2019
Phase: Phase 4
Study type: Interventional

The effect of an acute administration of hydroxychloroquine sulphate will be investigated on hedonic food intake, appetite related sensations and gastrointestinal hormone release in healthy female subjects.

NCT ID: NCT04005820 Not yet recruiting - Kidney Cancer Clinical Trials

Impact of Tumour 1q Gain in French Pediatric and Young Adult Patients With Renal Tumours

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

French patients with nephroblastoma (Wilms tumour, WT) have been treated for > 40 years according to International Society of Paediatric Oncology (SIOP) protocols with currently 267 centres across 28 countries collaborating internationally within the SIOP Renal Tumour Study Group (RTSG). Over the last decades more than 10,000 children have been prospectively enrolled in SIOP WT studies and trials. This has resulted in more standardised diagnostic procedures, improved risk stratification, and adjusted treatment recommendations for most renal tumours. The treatment of patients with renal tumours according to SIOP protocols include preoperative chemotherapy, surgery (tumour-nephrectomy + node-picking ± metastasectomy) followed by risk- and stage-based postoperative chemotherapy ± radiotherapy. Central pathology review is nowadays routinely performed in order to prevent misclassification of stage and histology risk group. The current SIOP 2001 protocol has come to an end with as major achievement the scientific proof of omitting doxorubicin in stage II and III patients with as a consequence less risk of sequelae. Moreover, in the SIOP 2001 protocol, several tumour biological aspects have been assessed that seem to interfere with outcome (chromosomal gain of 1q, or loss of 1p and 16q, blastemal residual volume). Chromosomal 1q gain is considered to be present in 25-35% of patients with nephroblastoma with a negative impact on event-free survival (EFS) in retrospective analyses. These biological aspects will be studied prospectively as a primary objective in the new SIOP RTSG 2016 UMBRELLA protocol that integrates diagnostics, treatment and follow-up guidelines as well as several research projects. The main mission of the International Society of Paediatric Oncology (SIOP) Renal Tumour Study Group (RTSG) is to increase survival and to reduce acute treatment toxicity and late effects in all children diagnosed with any renal tumour. In this context, SIOP RTSG is aiming to offer all these patients the same standardized high quality diagnostics and treatment, independent of the tumour type. The new SIOP RTSG 2016 integrated diagnostic and research UMBRELLA protocol serves as an entry for including all children with a renal tumour in the SIOP-RTSG centers, including prospective biomarker analyses. Subsequently, treatment is recommended according to the SIOP RTSG 2016 UMBRELLA treatment guidelines, which provides treatment strategies for all patients with Wilms tumour (WT) and other renal tumours. Central radiology review (CRR) has been proposed as a novel tool within the diagnostic UMBRELLA protocol in order to optimize the diagnostics and hence the treatment. The definition of metastatic disease in WT remains difficult since pulmonary nodules may not always be of malignant origin. The differential diagnosis of a pulmonary lesion seen in a child with WT is broad. In addition to malignancy, it includes atelectasis, fibrosis, pneumonitis, subpleural lymph nodes, and other infectious or inflammatory lesions. In addition, the issue of "CT-only" nodules in WT and adequate treatment needs to be solved. In previous protocols, the treatment strategy was based on the diagnosis of pulmonary metastases (92% of all metastases) by conventional pulmonary X-ray. Patients with CT-only nodules (= nodules not visible on conventional X-ray) were supposed to be treated as having localized WT. However, retrospective analyses of SIOP series (Smets et al), showed that patients with CT-only nodules had a less favourable prognosis as compared to patients with truly localized disease with a 12% difference in three-year event-free survival. The diagnostics of bilateral renal tumours (stage V) often is complicated since it may be difficult to distinguish true WT from nephroblastomatosis/ nephrogenic rests, a pre malignant renal (multifocal) anomaly, which may respond to preoperative chemotherapy. An optimal multi-disciplinary sequential diagnostic procedure is required in order to propose the best adapted therapeutic approach to preserve sufficient renal tissue.

NCT ID: NCT04010084 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease

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

Chronic obstructive pulmonary disease (COPD) is among the most common chronic respiratory diseases (CKD). Millions of people of all ages suffer from these diseases. COPD is between the fifth and sixth of the leading causes of death in Brazil. It generates an inflammatory pulmonary response that is softened by non-curative treatments and that present serious side effects. Low intensity laser (LBI) or laser therapy has been used for about 50 years to help the healing process, revealing efficient anti-inflammatory and analgesic responses, as well as experimental models of acute and chronic inflammation. However, little is known about its response in inflammatory lung diseases, especially COPD. Some reports indicate that laser therapy may interfere positively by relieving clinical signs, the onset, and the final symptoms of pulmonary inflammation. The present project aims to study the effects of LBI on Chronic Obstructive Pulmonary Disease in patients with pulmonary processes, determine their mechanisms of action and evaluate its effect on patients' functional capacity.

NCT ID: NCT04010669 Not yet recruiting - Portal Hypertension Clinical Trials

The Role of Somatostatin in the Hemodynamics of the Hepatic Circulation in Patients Undergoing Liver Resection

Start date: August 1, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of velocity and blood flow of the hepatic circulation in patients undergoing liver resection. The patients will be randomized in two groups: the study group will receive somatostatin and the control group will receive the placebo. In both groups, patients will undergo hepatectomy and directly postoperatively they will receive either somatostatin or placebo, depending on their randomization. The primary endpoint will be the increase or decrease of the velocity and the flow of the hepatic circulation estimated by ultrasonography compared to the same parameters when measured preoperatively.

NCT ID: NCT04012450 Not yet recruiting - Anesthesia Clinical Trials

The Effects of Combined Spinal-epidural Anesthetics During Labor

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

Women who fulfil the inclusion criteria and who intended to regional anesthesia will be randomized into the epidural anesthesia arm or to the spinal-epidural anesthesia arm. Sonographic evaluation of the flow in the uterine artery, umbilical artery, and middle cerebral artery will be documented to each patient prior and following the regional anesthesia.