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NCT ID: NCT03776617 Recruiting - Craniotomy Clinical Trials

Scalp Block in Elective Craniotomy for Tumor Dissection Trial

Start date: January 5, 2019
Phase: N/A
Study type: Interventional

This study was designed to evaluate the effect of scalp block combined with general anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients undergoing elective craniotomy. Scalp block will be applied to three groups with differences of the administered solution to the scalp and one group will be placebo group.

NCT ID: NCT03771404 Recruiting - Clinical trials for Non Small Cell Lung Cancer

NSCLC Heterogeneity in Early Stage Patients and Prediction of Relapse Using a Personalized "Liquid Biopsy"

Start date: January 5, 2018
Phase: N/A
Study type: Interventional

The purpose of his study is to investigate the intra tumor heterogeneity of the primary tumor and the involved lymph nodes from patients with resectable NSCLC, to detect primary tumor genetic alternations using "liquid biopsy" during the patients' clinical follow up and to correlate the "liquid biopsy" information with the disease recurrence.

NCT ID: NCT03768063 Recruiting - Cancer Clinical Trials

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

IMbrella B
Start date: February 28, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

NCT ID: NCT03739320 Recruiting - Clinical trials for Severe Eosinophilic Asthma

A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma

Start date: December 11, 2017
Phase:
Study type: Observational

Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.

NCT ID: NCT03738605 Recruiting - Breast Cancer Clinical Trials

Vaginal Laser Therapy in Breast Cancer Survivors

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.

NCT ID: NCT03727412 Recruiting - Aneurysm Abdominal Clinical Trials

Post Implantation Syndrome and Administration on NSAIDs in Patients Undergoing EVAR for AAA

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

INTRODUCTION Post-implantation syndrome is the clinical and biochemical expression of an inflammatory response following endovascular repair of an aortic aneurysm. PIS is mainly a clinical condition associated with the implantation of an endograft and is diagnosed by the presence of fever accompanied by elevated WBC count above normal without any evidence of an infection. The correlation between the type of the endograft placed and the development of PIS may indicate that the inflammatory reaction is due to the material of the endograft itself ( polyester or PTFE ). Based on the results of different studies the type of endograft's material seems to play an important role in PIS development and may have a predictive role for a significant number of patients undergoing endovascular repair of abdominal aortic aneurysm (EVAR). In most studies PIS is considered a benign condition, although it may lead to a more demanding postoperative care characterized by prolonged hospitalization. In an other prospective study patients with PIS were more likely to suffer from an adverse event during the 30 days after the procedure. The occurrence of PIS was the only independent predictor of a MACE ( major cardiovascular events ) or an adverse event during the follow-up period. Current available literature data certainly raise the question of altering current approach and treat patients with PIS by focusing on the reduction of the inflammatory response by administration of steroid or non-steroidal drugs. The aim of the present randomized placebo-controlled study is to evaluate whether the perioperative administration of Naproxen (NPR) an anti-inflammatory drug with a beneficial cardiovascular safety profile in patients with an abdominal aortic aneurysm undergoing endovascular repair could have any effect on the inflammatory response and patients outcome during the first year of follow-up after the surgery. METHOD PIS will be considered as the presence of fever (persisting body temperature > 38 ° C lasting more than 1 day during hospitalization) and leukocytosis ( white blood cell count > 12,000 / mL ) with negative blood and urine culture. All patients with AAA that will be subjected to EVAR in our department since February 2018 and who will receive an endograft made from polyester will be included in this study. All patients after being informed pre-operatively about the way and the purpose of the clinical study, the patients will be randomly selected to receive either naproxen ( NPR ) 500 mg x 2 or placebo, starting the previous day before the procedure and for 3 days postoperatively. The NPR was selected due to the expected significant anti-inflammatory activity and favorable cardiovascular safety profile. All patients presenting with fever during the post-operative period, whether or not fulfilling the PIS criteria, will undergo a thorough work up for possible infection. If any of these tests reveal evidence of an early pulmonary, urinary tract or any other kind of infection, the patient will not be considered to suffer from PIS. Patients will be discharged in the absence of any complications, with a body temperature < 38oC for at least 24 hours and a WBC < 12.000/mL. Besides the traditional inflammatory markers (WBC, hs-CRP, and fibrinogen ) the investigators will also measure interleukin 6 (IL-6) because it was the only marker significantly altered in PIS patients in a previous study. The follow-up will be performed at 1, and 12 months after surgery. Patient quality of life will also be studied by completing the SF36 questionnaire preoperatively and in the first year post-operative follow-up.

NCT ID: NCT03717350 Recruiting - Sepsis Clinical Trials

suPAR to Guide Antibiotics in Emergency Department

Start date: October 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients' final outcome. Since the traditionally used biomarkers (PCT, CRP) and scores (SOFA score) for early recognition of severity of infection fail to achieve maximum accuracy in all cases, suPAR levels are assessed as a probably better prognostic rule for early recognition of severe infections. The primary study endpoint will be the comparative efficacy of the early suPAR-guided administration of antibiotics versus standard practice on 28-day mortality.

NCT ID: NCT03714581 Recruiting - Dyspareunia Clinical Trials

Laser Therapy Following Radiotherapy for Gynecological Cancer

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

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

NCT ID: NCT03711032 Recruiting - Clinical trials for High-risk Non-muscle Invasive Bladder Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Start date: December 24, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

NCT ID: NCT03706820 Recruiting - Clinical trials for Exercise Pulmonary Hypertension

Exercise Hemodynamics in Patients With Pulmonary Fibrosis

Start date: May 7, 2018
Phase:
Study type: Observational

The study evaluates the rest and exercise hemodynamics of patients presenting either idiopathic fibrotic pulmonary disease or pulmonary fibrosis secondary to connective tissue disease.