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NCT ID: NCT03772054 Not yet recruiting - Clinical trials for Ischemia Reperfusion Injury

Sevoflurane vs Propofol Effect on Endothelial Damage Markers After Knee Ligament Surgery.

Start date: December 20, 2018
Phase: N/A
Study type: Interventional

Endothelial damage has been reported after ischemia-reperfusion events. This can be characterized by measurements of glycocalyx and endothelial components that are released to blood after the insult. Sevoflurane and inhaled anesthetic commonly used for surgery have shown protective endothelial effects in animal and in-vitro models. Knee-ligament surgery with the use of a femoral tourniquet generates a transient ischemia-reperfusion (IR) state after the tourniquet is released. This research aims to compare the effect of sevoflurane and propofol in the release of glycocalyx and endothelial biomarkers after IR in this surgical scenario.

NCT ID: NCT03762005 Recruiting - Septic Shock Clinical Trials

Peripheral Perfusion Versus Lactate Targeted Fluid Resuscitation in Septic Shock

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

Persistent hyperlactatemia has been traditionally considered as representing tissue hypoxia, and lactate normalization is recommended as a resuscitation target by the Surviving Sepsis Campaign (SSC). However, other sources contribute to hyperlactatemia such as sustained adrenergic activity and impaired lactate clearance. Only hypoperfusion-related hyperlactatemia might be reversed by optimizing systemic blood flow. Fluid resuscitation (FR) is used to improve cardiac output (CO) in septic shock to correct hypoperfusion. Nevertheless, if persistent hyperlactatemia is not hypoxia-related, excessive FR could lead to flow overload. In addition, kinetics of recovery of lactate is relatively slow, and thus it might be a suboptimal target for FR. Peripheral perfusion appears as a promising alternative target. Abnormal capillary refill time (CRT) is frequently used as trigger for FR in septic shock. Studies demonstrated the strong prognostic value of persistent abnormal peripheral perfusion, and some recent data suggest that targeting FR on CRT normalization could be associated with less fluid loading and organ dysfunctions. The excellent prognosis associated with CRT recovery, the rapid-response time to fluid loading, its simplicity, and its availability in resource-limited settings, constitute a strong background to promote studies evaluating its usefulness to guide FR . The study hypothesis is that a CRT-targeted FR is associated with less positive fluid balances, organ dysfunctions, and at least similar improvement of tissue hypoperfusion or hypoxia, when compared to a lactate-targeted FR. To test this hypothesis, the investigators designed a clinical physiological, randomized controlled trial in septic shock patients. Recruited patients will be randomized to FR aimed at normalizing CRT or normalizing or decreasing lactate >20% every 2 h during the study period. Fluid challenges (500 ml in 30 min intervals) will be repeated until perfusion target is achieved, or dynamic predictors of fluid responsiveness become negative, or a safety limit is reached. The design of our study is aimed at: a) determining if CRT targeted resuscitation is associated with less fluid resuscitation and fluid balances; b) determining if this strategy is associated with less organ dysfunctions; and c) if it results in similar improvement in markers of tissue hypoperfusion or hypoxia such as hepato-splanchnic blood flow or microcirculatory perfusion.

NCT ID: NCT03744065 Recruiting - Pain, Postoperative Clinical Trials

Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required. In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting. Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.

NCT ID: NCT03741439 Recruiting - Clinical trials for Erectile Dysfunction

RCTrial to Test Low Intensity Shockwave Treatment in Patients With Mild/Moderate Erectile Dysfunction

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

Even though, the efficacy of Low-Intensity Shockwave Therapy (LIST) to treat Erectile Dysfunction (ED) has been documented by numerous trials; it is still not recommended by clinical guidelines. Different types of: shockwave generators, treatment protocols and ED severities of patients included in the studies, explain the lack of recommendations for a standard treatment. Ideally, each shockwave generator should have its own efficacy data from randomized controlled trials, using standardized protocols, and in defined populations. Objective: to test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial. Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED. After ending T3 we expect to treat placebo patients to see impact of changing arm study.

NCT ID: NCT03735121 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous in Patients With Stage IV Non-Small Cell Lung Cancer

Start date: December 28, 2018
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) in patients with Non-Small Cell Lung Cancer (NSCLC). A dose-finding part (Part 1) will aim to identify the dose of atezolizumab SC that yields drug exposure that is comparable to that of atezolizumab IV. A dose-confirmation part (Part 2) will aim to demonstrate the non inferiority of observed drug exposure following treatment with atezolizumab SC at the identified dose compared with historical drug exposure following treatment with atezolizumab IV.

NCT ID: NCT03733509 Recruiting - Knee Osteoarthritis Clinical Trials

Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty

Start date: November 12, 2018
Phase: N/A
Study type: Interventional

This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.

NCT ID: NCT03732820 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Start date: October 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

NCT ID: NCT03732677 Recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Start date: November 16, 2018
Phase: Phase 3
Study type: Interventional

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

NCT ID: NCT03721289 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Evaluation in Real World of Molecular Testing and Treatment Patterns for EGFR Mutation in Lung Cancer Patients

Start date: November 29, 2018
Study type: Observational

Evaluate molecular testing and treatment patterns for EGFR mutation in two different cohorts of stage IV NSCLC, at diagnosis (treatment naïve) and at the moment of progression to EGFR-TKIs. This study is non-indication seeking (NIS), descriptive in nature and does not attempt to test any specific a priori hypotheses.

NCT ID: NCT03705338 Not yet recruiting - Anesthesia Clinical Trials

Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol

Start date: October 15, 2018
Study type: Observational

Anesthesia is essential to control pain and produce unconsciousness during surgery and other procedures during childhood. The anesthetic deepness is measured indirectly through changes in blood pressure and heart rate or can be inferred according to estimated or measured concentrations of anesthetics. In adults, anesthetic dosing, using patterns based on electroencephalogram (EEG) analysis, has shown clinical advantages compared to traditional monitoring. These advantages include lower consumption of hypnotics, less post-operative cognitive deterioration and decreased intraoperative awakening. The maturation of the brain and Central Nervous System (CNS) that occurs in childhood affects the response of anesthetics. Additionally, the EEG changes with age and its dominant frequency is lower in children. This explains why brain monitoring methods developed in adults do not work well in children. However, these patterns cannot be extrapolated to the pediatric population. Therefore, it is necessary to develop indexes based on EEG with pediatric data to improve the dosage of hypnotics in this population. The appearance of alpha wave in frontal EEG has been successfully used as a marker of unconsciousness during general anesthesia with GABAergic hypnotics in adults (sevoflurane, propofol). However, in children, the alpha wave appears since 4 months of age in anesthetics with sevoflurane, so studying the characterization of this wave during the loss and recovery of secondary consciousness anesthetic agents such as propofol has not been studied yet.