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NCT ID: NCT03197935 Not yet recruiting - Clinical trials for Triple-negative Breast Cancer

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

IMpassion031
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac−AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

NCT ID: NCT03196271 Recruiting - Clinical trials for Intractable Epilepsy

Ketogenic Diet Drink Study

Start date: January 4, 2017
Phase: N/A
Study type: Interventional

An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated.

NCT ID: NCT03196128 Recruiting - Clinical trials for First Episode Psychosis

Early Intervention Psychosis Communication and Engagement Trial

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

This study will examine whether or not the use of digital communication methods (text messages and emails) improves patient engagement with Early Intervention Psychosis (EIP) Services, compared to standard communication methods (letters and telephone calls). One of the biggest challenges of psychiatric services is patient disengagement. People with psychosis, are often difficult to engage in community based mental health services (CMHTs). Patient's who disengage from psychiatric care often have higher social care needs, are often more unwell and are more likely to be detained under the Mental Health Act compared to those who engage. It is important to examine the reasons for this for both research and clinical reasons to establish the effectiveness of the service to its users. Importance must be placed on the clinician's perspective of the engagement; the patient's perspective is vital. This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility of assessing engagement of EIP services through different communication methods. Patients and care-coordinators will use self-reported scales to measure engagement to determine whether this improves through the use of different communication methods. Patients will be asked to consent to being randomly allocated to one of two groups: (i.) Receive letters, phone calls and voicemail's from their care coordinator for standard appointments. OR (ii.) Receive text messages and emails from their care-coordinator for standard appointments. Patients eligible for this study will be in their first six months of care under an EIP CMHT and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have access to the Internet, a mobile phone and who are fluent in the English language. Care-coordinators will assess the feasibility and acceptability of the design and procedures and determine an effective sample size calculation for a future large scale pragmatic Randomised Controlled Trial.

NCT ID: NCT03195985 Not yet recruiting - Mindfulness Clinical Trials

Mindfulness in Old Adults With Subjective Cognitive Complaints

Start date: July 2017
Phase: N/A
Study type: Interventional

The study will focus on measuring stress, rumination and cognitive function across three time points in old adults with subjective cognitive complaints via a 4-week short mindfulness intervention, as compare to an active control condition (psycho-education course "ge Well"). This is a pilot study.

NCT ID: NCT03195946 Recruiting - Drug Reactions Clinical Trials

Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Start date: June 16, 2017
Phase: Phase 1
Study type: Interventional

This study will help determine which types of drugs that may interact with Lu AF35700

NCT ID: NCT03195647 Not yet recruiting - Cardiac Arrythmias Clinical Trials

Pilot Study for the Tight K Study

TightK
Start date: August 1, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this pilot study will be feasibility of recruitment. However, in order to further inform a full randomised controlled trial (RCT), information on the incidence of AF and other arrhythmias, hospital length of stay, resource use and morbidity will be collected.

NCT ID: NCT03195348 Recruiting - Sleep Disturbance Clinical Trials

The Effects of Whole Body Unloading on Physiological Function

Start date: March 29, 2017
Phase: N/A
Study type: Interventional

This study is a collaboration between the Centre of Human & Aerospace Physiological Sciences (CHAPS) and the Sleep and Brain Plasticity Centre (Department of Neuroimaging) at King's College London and the Sleep Disorders Centre at Guy's Hospital.The main purpose of the study is to evaluate the effects of a 7 day unloading period (simulating micro gravity) on muscle mass using three independent methods; two scanning techniques (magnetic resonance imaging (MRI) and dual x-ray absorptiometry (DXA)) and one that involves swallowing a capsule that contains a harmless chemical called creatine (D3-Creatine (D3-cr)) and then measuring its concentration in urine. In order to induce muscle loss, participants will be required to lie flat on their back on a water bed filled with water and salt (called hyper-buoyancy flotation (HBF)). As this situation is similar to that experienced in space, the investigators will also measure the effect of HBF on sleep, brain and physiological function - all things known to change in astronauts. Sixteen male subjects (18-40 yrs) will be recruited to participate in the study that will require physiological testing before, during and following both 7 days of normal conditions and 7 days of HBF bed-rest. Each subject will be exposed to the same conditions and assessments over the study period. As some loss of muscle is expected, participants will be offered an exercise rehabilitation programme upon completion of HBF with self-monitored and/or guided sessions based on those provided by the Space Medicine Office of the European Space Agency to returning astronauts.

NCT ID: NCT03194815 Not yet recruiting - Psychosis Clinical Trials

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

SINAPPS2
Start date: July 2017
Phase: Phase 2
Study type: Interventional

A randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel). Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes. Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.

NCT ID: NCT03194269 Not yet recruiting - Prominent Ears Clinical Trials

Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears

FOLD
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.

NCT ID: NCT03193294 Recruiting - Coronary Disease Clinical Trials

CORonary MICrovascular Angina (CorMicA)

CorMicA
Start date: November 7, 2016
Phase: N/A
Study type: Interventional

Angina is form of chest pain that is due to a lack of blood to the heart muscle. Angina is commonly triggered by stress and exertion, and is a common health problem worldwide. The diagnosis and treatment of angina is usually focused on detection of blockages in heart arteries, and relief of this problem with drugs, stents or bypass surgery. However, about one third of all invasive angiograms that are performed in patients with angina do not reveal any blockages. Many of such patients may have symptoms due to narrowings in the very small micro vessels (too small to be seen on an angiogram). The purpose of this research is to undertake a 'proof-of-concept' clinical trial to gather information as to whether routine tests of small vessel function in the heart might help identify patients with a stable coronary syndrome due to a disorder of coronary function (vasospastic or microvascular angina), and appropriately rule out this problem in patients with normal test results. The diagnostic strategy enables stratification of patient sub-groups to optimized therapy (personalised medicine). Evidence of patient benefits in this study would support the plan for a larger study that would be designed to impact on healthcare costs and patient reported outcome measures (PROMS).