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NCT ID: NCT01920061 Completed - Neoplasm Clinical Trials

A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

Start date: September 10, 2013
Phase: Phase 1
Study type: Interventional

This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

NCT ID: NCT01920048 Completed - Clinical trials for Ischemic Cardiomyopathy

Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure

REVIVED-BCIS2
Start date: August 28, 2013
Phase: N/A
Study type: Interventional

This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.

NCT ID: NCT01920022 Completed - Medical Abortion Clinical Trials

Quickstart of Nexplanon® at Medical Abortion

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.

NCT ID: NCT01920009 Completed - Clinical trials for Coronary Heart Disease

Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines

Pharmacycare
Start date: September 2013
Phase: N/A
Study type: Interventional

Introduction: In the United Kingdom(UK), about 838,000 men and 394,000 women have had a myocardial infarction (MI) and will need secondary prevention medications. Longterm adherence to secondary prevention therapies remains poor, nonadherence to medication in MI patients ranges from 13-60%(1). Studies show that approximately one fourth of cardiac patients do not refill their cardiac medications (2). Strategies to tackle the burden of non adherence could involve pharmacy care and The New Medicine Service (which is a service provided by community pharmacists to help patients on long term medications for chronic diseases) with a motivational interview incorporated as part of the counselling session of a community pharmacist. Communication of health providers with patients and between health providers could also be an important strategy to improve adherence. Cardiovascular disease is high in all ethnic groups as well as in the general population; however it is the South Asians who have the highest prevalence of coronary heart disease (CHD) (3). In addition, South Asians develop CHD at a younger age, often before the age of 40 years (3). Aim of this study: This study is to investigate the feasibility and potential impact of a pharmacy care intervention involving motivational interviews and referral to the New Medicine Service in coronary heart disease patients on adherence to secondary prevention medication and on outcomes of coronary heart disease. Method: The study is designed as a prospective, controlled feasibility/pilot, intervention study. The study has two phases. In the intervention phase a total of 200 coronary heart disease patients discharged from the London Chest Hospital will be enrolled into the study and followed up for one year. Pharmacies from up to six London Boroughs will be invited to take place in the study. Pharmacies will be randomised using a table of random numbers into intervention site or control site. The pharmacists working in the intervention pharmacies will be invited for training on the delivery of the intervention and on motivational interviewing. The intervention will be performed by community pharmacists. Recruitment of patients will take place in the hospital. In the interview phase 20 patients from South Asian backgrounds will be invited for a telephone interview to study the effect of their beliefs and cultural backgrounds in regards to their adherence to cardiac medication. Outcome measures: The primary outcome measure is self report adherence with coronary artery disease medication employing a standard validated measure. Secondary outcomes are blood pressure and LDL-C (low density lipoprotein cholesterol) in addition to data regarding the feasibility of the intervention. Analysis: Both quantitative and qualitative data analysis will be performed.

NCT ID: NCT01919801 Completed - Clinical trials for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.

NCT ID: NCT01919294 Completed - Hypogonadism Clinical Trials

Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)

TEREPINS
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months 1. improve severity of steatosis on liver biopsy (Primary Question)? 2. improve severity of associated steatohepatitis on liver biopsy? 3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)? The work proposed here is an open pilot study of 10 patients, the main aim of which is to assess the effect size of TRT in regard to these end points (regarding which there are no published data), thereby allowing power calculations for a more definitive phase II trial. Other aims would be assessing recruitment and consent rates, which would also inform the design of the larger study.

NCT ID: NCT01919021 Completed - Clinical trials for Functional Dyspepsia

Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging

Start date: April 2011
Phase: N/A
Study type: Interventional

Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on quality of life and health care costs. When no structural cause is identified, patients are diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of stomach function that explain patient's symptoms and establish diagnosis. Another group are diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis. In some cases this is associated with delayed gastric emptying but not all. 24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia. The utility of 3 different non-invasive investigations will be assessed. At screening the nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every minute and score symptoms every 5 minutes. The patient continues until they reach the maximum tolerated volume. Participants will then be randomized to undergo non-invasive imaging on two separate test days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional calories) of known breaking strength. The emptying of the stomach will be visualised with the MRI alongside symptom recording. Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling will allow the rate of liquid and solid meal emptying to be visualised alongside symptom recording. Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30 minutes following ingestion of 400ml of milkshake and 12 agar beads. Data will be analyzed to assess the association of objective abnormalities of gastric function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS will be compared to assess the optimal measurement of gastric function and emptying in this clinical scenario.

NCT ID: NCT01918735 Completed - Epilepsy Clinical Trials

A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of single ascending (increasing) and multiple doses of GWP42006 compared with placebo.

NCT ID: NCT01917513 Completed - Colorectal Cancer Clinical Trials

Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy

NCT ID: NCT01917162 Completed - Refractive Error Clinical Trials

Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.