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NCT ID: NCT02433613 Completed - Atrial Fibrillation Clinical Trials

Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

Start date: March 2015
Phase:
Study type: Observational [Patient Registry]

Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance. Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

NCT ID: NCT02433561 Completed - Shoulder Pain Clinical Trials

Intra- Versus Extraplexic Catheter Placement for Continuous Interscalene Brachial Plexus Block

Start date: November 2015
Phase: Phase 4
Study type: Interventional

Continuous interscalene brachial plexus block consists of inserting a catheter directly within the brachial plexus in the interscalene groove, between the middle and anterior scalene muscles, which is then infused with local anesthetic. This technique provides potent and site-specific analgesia for several days after major shoulder surgery, along with increased shoulder range of motion. A major side-effect of this procedure is the paralysis of the ipsilateral diaphragm, which is the main muscle of the respiration. This paralysis occurs at a rate of 90 to 100%, and is due to the spread of the local anesthetic towards the phrenic nerve, lying anteriorly to the plexus, between the sternocleidomastoid and anterior scalene muscles. Therefore, many patients suffering from respiratory syndromes, such as chronic obstructive pulmonary disease, will not have a continuous interscalene brachial plexus block, thus forfeiting some, or all, of the aforementioned benefits associated regional anesthesia. It is conventionally taught to place the needle tip between the nerve roots of the brachial plexus to obtain an effective block (intra-plexic injection). Recently, we have published a new technique of single-shot injection for interscalene brachial plexus block where the needle tip was positioned at a distance of 4 mm of the lateral part of the brachial plexus (extra-plexic injection) and resulted in a reduction rate of 70% of hemidiaphragmatic paresis and a preservation of spirometric values, while providing similar analgesia, when compared to a conventional injection. Contrary to single-shot injections where high volume and high concentration of local anesthetics are injected (eg, ropivacaine 0.5%, 20 mLs), continuous blocks required low volume and low concentration (eg, ropivacaine 0.1-2%, 2-6 mLs/h) and therefore the aforementioned concept of extra-plexic technique might not be suitable. Recently, new catheter-over-the needle (Contiplex® C; B. Braun Melsungen AG, Germany) have been released on the market and allows the physician to place the catheter tip exactly where he desires, contrary to the previous generations where the catheters were inserted blindly, despite the use of ultrasound. The first objective of that randomised controlled trial is to demonstrate that an extra-plexus catheter placement produces less respiratory complications than an intra-plexus catheter placement. The second objective is to confirm that both techniques provide similar analgesia.

NCT ID: NCT02433548 Completed - Clinical trials for Femoral Neck Fracture

Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain. Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.

NCT ID: NCT02433379 Completed - Clinical trials for Ventricular Tachycardia

Understanding Outcomes With the EMBLEMâ„¢ S-ICD in Primary Prevention Patients With Low Ejection Fraction

UNTOUCHED
Start date: June 9, 2015
Phase: N/A
Study type: Interventional

This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

NCT ID: NCT02433054 Completed - Clinical trials for Post-thrombotic Syndrome

Bern Venous Stent Registry

Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to examine patency rates of self-expanding nitinol stents for treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Moreover, clinical outcome data of patients treated with these venous stents will be collected.

NCT ID: NCT02433041 Completed - Clinical trials for Postoperative Delirium

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

PRIDe
Start date: July 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.

NCT ID: NCT02433028 Recruiting - Multiple Sclerosis Clinical Trials

Swiss Multiple Sclerosis Cohort-Study

SMSC
Start date: June 2012
Phase:
Study type: Observational

The Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are 1. To maintain a long-term cohort for an undefined duration of patients with Multiple Sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in Switzerland. This requires effective measures to limit drop-outs and the continuous recruitment of MS patients and 2. To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids. The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data. Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the: 1. Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response. 2. Exploration of the safety and impact on long-term disability of existing and next generation MS treatments 3. Individualized therapy: A number of highly active but potentially also harmful therapies have lately been established for the treatment of MS. To date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it. 4. Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.

NCT ID: NCT02431559 Completed - Ovarian Cancer Clinical Trials

Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer

Start date: December 2, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is an ongoing Phase 1/2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with recurrent, platinum-resistant ovarian cancer who are scheduled to receive pegylated liposomal doxorubicin (PLD).The primary objective of Phase 1 is to determine the maximum tolerated dose (MTD) and safety profile, with a secondary objective to evaluate the clinical efficacy as measured by progression-free survival (PFS) rate at 6 months (PFS-6). The primary objective of Phase 2 is the evaluation of clinical efficacy as measured by PFS-6. For both phases, secondary objectives include evaluation of clinical efficacy as measured by overall response rate, PFS, and overall survival (OS), safety and tolerability, and immunological responses.

NCT ID: NCT02430363 Enrolling by invitation - Glioblastoma Clinical Trials

Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

It is known that after application of MK-3475 activated PD -1 negatively regulates the activation of T cells through suppression of the path of PI3K / Akt. This study will identify the effectiveness of oral inhibitors of PI3K / Akt pathway in comparison with MK-3475 (pembrolizumab).

NCT ID: NCT02429154 Completed - Hypercapnia Clinical Trials

Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)

VARO
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.