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NCT ID: NCT02428062 Suspended - Clinical trials for Post-operative Cognitive Dysfunction

Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

THE BRIDGE
Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss of brain functions observed in elderly patients after surgical operations under general anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70 years and more, and the only recognized risk factor for this condition is increasing age. Importantly, the incidence of POCD at 3 months has been associated to an increased disability and mortality. OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at maintaining intra-operative arterial blood pressure close to patient's preoperative blood pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three months. METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be evaluated preoperatively and at 3 months and 1 year postoperatively, together with the occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of postoperative delirium and cardiovascular, respiratory and infectious complications will be evaluated. EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD at 3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1 postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3 months, a reduction in the incidence of delirium. Hospital length of stay and 90 day mortality will also be assessed. This present study could have a high socio-economic impact, reduce healthcare costs and patient morbidity and mortality with a simple not expensive intraoperative intervention.

NCT ID: NCT02391467 Suspended - Clinical trials for Hepatitis B Virus Infection; Pregnant Women

Validity of Elastography During Pregnancy

Start date: December 2014
Phase: N/A
Study type: Observational [Patient Registry]

Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

NCT ID: NCT02356991 Suspended - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

Start date: December 2014
Phase: Phase 2
Study type: Interventional

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable. The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).

NCT ID: NCT02283931 Suspended - Clinical trials for Obstetric Anesthesia, Cardiac Monitoring

Cardiac Output Changes With Uterine Displacement

LUDCO
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

There is currently little information regarding the hemodynamic differences in uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine. Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.

NCT ID: NCT02223975 Suspended - Clinical trials for Squamous Cell Carcinoma

Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease

Vulval VS
Start date: August 2014
Phase: N/A
Study type: Observational

Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin disorders are common and the diagnosis of these conditions can be difficult. Reliable discrimination between benign vulval skin conditions, precancerous conditions or vulval cancer often requires tissue biopsies. In addition the monitoring of patients with vulval disease at risk cancerous change is currently limited to visual assessment often supplemented by multiple invasive tissue biopsies. There are currently no established non invasive tests available for the diagnosis of vulval skin diseases. The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared spectroscopy are non invasive diagnostic tools that use the interaction of light within tissues to identify the chemical composition of different tissues. The use of these tools may reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease. The aim of this project is to explore the use of vibrational spectroscopic techniques in the diagnosis of vulval skin disease. This will be achieved by performing vibrational spectroscopy on samples of tissue previously taken from women with vulval skin disease treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy will be compared with the routine tests and the accuracy of spectroscopy determined.

NCT ID: NCT02202369 Suspended - Clinical trials for Single Level Lumbar Decompression and Fusion Spine Surgery

Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

Start date: June 25, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to usual analgsic care.

NCT ID: NCT02156180 Suspended - Clinical trials for Oropharyngeal Squamous Cell Carcinoma

Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

Start date: April 2014
Phase: N/A
Study type: Observational

In this study the Investigators aim to determine specific volatile compounds present in breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before and after tumour resection or before and after chemotherapy +/- radiotherapy using gas chromotography-mass spectrometry. The Investigators hypothesize that study participants with a tumour will display a distinct set of volatile organic compounds than can serve as potential cancer biomarkers.

NCT ID: NCT02122185 Suspended - Clinical trials for Recurrent Ovarian Epithelial Cancer

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Start date: February 25, 2015
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors learn more about the effects of metformin hydrochloride on cells. It may also help doctors understand how well patients respond to treatment. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells.

NCT ID: NCT02117336 Suspended - Clinical trials for Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Clinical Study of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Start date: June 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, Phase I/Ib trial with a dose escalation phase, followed by a dose extension phase. The objective of the dose escalation phase is to evaluate the pharmacokinetics (PK) and MTD of P1446A-05 in relapsed/refractory CLL and the objective of the dose extension phase is to evaluate the safety, efficacy and pharmacodynamics of P1446A-05 in 14 patients at the MTD level.

NCT ID: NCT02037529 Suspended - Clinical trials for Invasive Breast Carcinoma

Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer

Start date: January 17, 2014
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Drugs used in chemotherapy, such as eribulin mesylate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.