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NCT ID: NCT02593539 Completed - Clinical trials for Activated PI3K-delta Syndrome

Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI

Start date: July 22, 2016
Phase: Phase 2
Study type: Interventional

This is an open-label study conducted to investigate safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled nemiralisib (NEMI) in participants with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110 delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI)

NCT ID: NCT02593045 Completed - Clinical trials for Cutaneous T-Cell Lymphoma

Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

Start date: October 2015
Phase: Phase 1
Study type: Interventional

The primary objective of this first in human study is to assess the safety and tolerability of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a Maximum Tolerated Dose (MTD).

NCT ID: NCT02592837 Completed - Lung Cancer Clinical Trials

EBUS-TBNA vs Flex 19G EBUS-TBNA

Start date: May 2016
Phase: N/A
Study type: Interventional

Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides needle aspirate samples which are often adequate for cytological examination only. More advanced histopathological and immunocytopathological assessment of tissue samples, which is particularly important in the diagnosis and staging of cancer, is often not possible with the small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more flexibility at the distal end, allowing better access to some lymph nodes stations. This needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather than cytological assessment alone. This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or more invasive surgical biopsies, without causing an increase in complication rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month period.

NCT ID: NCT02592577 Completed - Clinical trials for Non-Small Cell Lung Cancer

MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC

Start date: November 2015
Phase: Phase 1
Study type: Interventional

This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose escalation trial that will evaluate 3 doses of transduced cells administered after a lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose. Subjects will be seen frequently by the Study Physician right after receiving their T cells back and up to first 6 months. After that, subjects will be seen every three months. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next 10 years. Subjects who have a confirmed response or clinical benefit ≥4 weeks after the first T-cell infusion and whose tumor continues to express the appropriate antigen target may be eligible for a second infusion. All subjects, completing or withdrawing from the Interventional Phase of the study, will enter a 15-year long-term follow-up phase for observation of delayed adverse events. All subjects will continue to be followed for overall survival during the long-term follow-up phase.

NCT ID: NCT02592434 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Efficacy Study Of Tofacitinib In Pediatric JIA Population

Start date: June 10, 2016
Phase: Phase 3
Study type: Interventional

Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.

NCT ID: NCT02592369 Completed - Clinical trials for Aortic Valve Stenosis

CoreValve™ Evolut R™ FORWARD Study

FORWARD
Start date: January 2016
Phase:
Study type: Observational

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

NCT ID: NCT02591901 Completed - Neurogenic Bladder Clinical Trials

Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)

PReSuTINeB
Start date: April 6, 2018
Phase: Phase 2
Study type: Interventional

Due to the damage caused to the spinal cord, patients with spinal cord injury, cauda equina syndrome, multiple sclerosis and transverse myelitis may encounter loss of bladder function, which in turn can lead to a debilitating and costly complication: Urinary Tract Infections (UTIs). Given that these patients with loss of bladder function do not normally feel symptoms like pain - as would be the case in otherwise healthy persons - there is no clear agreement among experts on which signs and symptoms are indicative of a UTI. Although strong evidence is lacking, antibiotics have been widely used for prevention of recurrent UTIs in patients with loss of bladder function. However, this approach is now being questioned as antibiotic resistance has become a world-wide health concern. Policy makers recently stressed the importance of research into alternative preventative treatments. The use of immunotherapy is one such an alternative approach, which works by stimulating the body's immune system. One of these immunotherapy is a Uro-Vaxom® oral capsule which consists of inactivated traces of the bacteria that normally cause at least 83% of UTIs in patients with loss of bladder function. Previous studies show that Uro-Vaxom® resulted in a significant reduction of UTIs in otherwise healthy patients, as well as being safe to use. Before investigating the effects of this promising new immunotherapy, this proposed study aims to clarify two crucial issues. First, after reviewing the literature and appraising patients', carers' and healthcare professionals' experiences, the aim is to reach an agreement on how to measure a symptomatic UTI in patients with loss of bladder function that results from a spinal cord lesion. Second, using Uro-Vaxom® Investigators aim to conduct a smallscale, placebo-controlled trial with 48 participants to investigate the feasibility of carrying out a larger trial on prevention of symptomatic UTI in such patients.

NCT ID: NCT02591134 Completed - Weight Clinical Trials

EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss

SWITCH
Start date: July 2016
Phase: N/A
Study type: Interventional

The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological indices of appetitive behaviour have not been assessed in both weight loss and maintained weight loss phases over the long term to determine whether NNS beverages may assist in efforts to lose weight and maintain weight loss and how this affects appetite expression (satiety, food choice, craving, ease of dieting etc.). Thus the present research will determine the impact of NNS beverages as compared to water on weight loss and weight loss maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state across both a period of weight-loss as well as a weight-maintenance phase. To determine if the effects of NNS on appetite are beneficial or detrimental to successful weight management, the study will also systematically compare the effects of NNS beverages, water and caloric beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy intake (including food choice and caloric compensation) across the whole day during active weight management in a subset of participants.

NCT ID: NCT02590796 Completed - Dementia Clinical Trials

Validating Studies to Assess the Diagnostic Accuracy of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium

Start date: October 12, 2015
Phase:
Study type: Observational

The study has two phases: Phase B and Phase C. The purpose of the Phase B study is to determine the performance (sensitivity and specificity) of a smartphone application (DelApp) to identify delirium in the whole inpatient sample. The study also aims to determine the performance (sensitivity and specificity) of the DelApp to discriminate between delirium (with or without dementia) and dementia (without delirium). The purpose of the Phase C study is to determine the efficacy of the DelApp software application in detecting delirium in unselected patients in an inpatient sample and to determine the performance of the DelApp to discriminate between delirium and dementia. The study also aims to explore the performance of the DelApp in tracking change in cognitive function.

NCT ID: NCT02589808 Completed - Echocardiography Clinical Trials

Preoperative Pocket Echocardiography Trial

POPPET
Start date: July 2015
Phase: N/A
Study type: Interventional

This study will compare findings using a handheld ultrasound device (GE VScan) with those using a diagnostic ultrasound machine in adult patients referred for transthoracic echo (TTE), prior to non-cardiac surgery at Hammersmith Hospital, London. The handheld TTE (VTTE) will follow the standard Hammersmith Hospital diagnostic TTE (DTTE) protocol (with the exception of spectral Doppler) and will be reported on a simple 'tick box' form. A different echocardiographer will then perform and report the DTTE as per routine practice. The results from VTTE and DTTE will be directly compared. The echocardiographers performing the VTTE and DTTE are all fully accredited in diagnostic TTE and will be blinded to each others findings. The study aims to recruit a total of 96 patients with an anticipated study completion date of November 2015.