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NCT ID: NCT02085213 Completed - Placenta, Retained Clinical Trials

GOT-IT Trial: Glyceryl Trinitrate for Retained Placenta

GOT-IT
Start date: September 2014
Phase: Phase 4
Study type: Interventional

A retained placenta (RP) is a complication after a normal birth, which affects nearly 11,000 women in the UK per year. This is where the placenta is not delivered spontaneously after giving birth. It is a major cause of postpartum haemorrhage (major loss of blood) which can lead to the death of the mother. The recommended treatment for RP is a surgical procedure - manual removal of placenta (MROP). This is a painful and unpleasant intervention for the women, involving additional hospital stay, and is an expensive outcome for the NHS. It is widely recognised that non-surgical management options for RP are limited and it has been recommended that research is needed into new medical treatments for RP. New effective treatments for RP would dramatically reduce the number of women requiring MROP with the operation being restricted to the small minority of women with particularly stuck placentae. The reduction in operative interventions would have cost benefits for the NHS and also for women in terms of increased satisfaction, less separation of mother and baby immediately after birth, and reduced morbidity. This study will try to prove the clinical and cost effectiveness of a known treatment for angina, Glyceryl trinitrate (GTN) used to treat RP. The investigators will compare GTN against a placebo (dummy treatment) in a randomised controlled blinded trial (GOT-IT). The GOT-IT Trial will be conducted in two phases. The first phase will involve an internal pilot study where the aim will be to test out and refine trial procedures in a small number of hospital sites. The second phase will be the main trial where recruitment will be extended to a larger number of hospitals in order to determine clinical and cost effectiveness.

NCT ID: NCT02085161 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

NCT ID: NCT02085148 Completed - Pediatric Oncology Clinical Trials

A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy

Start date: April 11, 2014
Phase: Phase 1
Study type: Interventional

Dose escalation phase of the study : To define the safety profile, maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on/1- week-off schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors recurrent or refractory to standard therapy. To characterize the pharmacokinetics (PK) of regorafenib The dose escalation phase of the study has been completed. Expansion phase: To define the safety profile, MTD and the RP2D of regorafenib administered orally in combination with backbone chemotherapy (vincristine and irinotecan) at relapse in pediatric subjects with rhabdomyosarcoma (RMS) and other solid malignant tumors recurrent or refractory to standard therapy.

NCT ID: NCT02085018 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)

PPIPF
Start date: March 28, 2014
Phase: Phase 2
Study type: Interventional

Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with the disease die after approximately 3 years. The most common, troublesome symptoms of IPF are breathlessness on exertion, and cough. No drug treatments have been unequivocally shown to improve the death rate, or to significantly impact upon symptoms, in IPF. In recent years it has been recognised that cough can be caused by small amounts of liquid coming up from the stomach and "going down the wrong way" into the lungs, a process commonly known as "reflux". As liquid in the stomach is usually acidic, patients' lungs may repeatedly be exposed to small amounts of acid. Reflux is unusually common in IPF and could potentially contribute to the debilitating cough found with the disease. However there are many potential causes for cough in IPF. Stomach acid can be efficiently "switched off" by drugs called "proton pump inhibitors", one of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF, omeprazole might be expected to reduce cough. The purpose of this study is therefore to test whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the doctor will be aware which treatment has been given, ie this is a randomised "double-blind", placebo--controlled trial. Patients' cough frequency will be measured before and after treatment and the change in cough frequency compared in those receiving omeprazole and those receiving placebo. Change in cough frequency is the main thing we aim to compare, but a range of other measurements will be assessed such as the numbers of patients eligible to take part, agreeing to randomisation and providing outcome data, patients' lung function, symptom scores, the amount of reflux, and the amount of inflammation in the lungs.

NCT ID: NCT02084485 Completed - Healthy Clinical Trials

PH-797804 LPS Study in Healthy Volunteers

Start date: September 2006
Phase: Phase 1
Study type: Interventional

The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for patients with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT02083965 Completed - Severe Hemophilia A Clinical Trials

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

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

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

NCT ID: NCT02083406 Completed - Malaria Clinical Trials

Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)

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

A single dose study to investigate how different formulations of OZ439 co-administered with PQP tablest are processed by the body when taken without food

NCT ID: NCT02083029 Completed - Asthma Clinical Trials

Vagal Nerve Stimulation Assessed by the Diving Reflex: An Investigation Into Mechanisms of Asthma Death

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

The investigators' hypothesis is that dysregulation of autonomic function, as revealed during a simulated dive reflex, may result in an attenuation of the heart rate response to a greater degree in asthmatics who collapse during exacerbations of asthma than that seen in healthy individuals and in asthmatics without a history of syncope. The investigators will test this by assessing autonomic function through a dive reflex protocol.

NCT ID: NCT02082730 Completed - Clinical trials for Chronic Fatigue Syndrome

The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population

ASARM
Start date: January 2013
Phase: N/A
Study type: Interventional

This study aims to improve on the delivery of treatment for people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). People with CFS/ME have low energy. This interferes with doing everyday activities and has a major impact on quality of life. Energy management is a key aspect of treatment and involves patients building up their energy levels gradually. Their health professional finds out how much energy the patient uses daily so they can prescribe how much activity and rest is right for the patient. The prescription is adjusted throughout treatment. Over time, the patient learns the best way to "spend" and "preserve" energy. To begin treatment, patients record their activity levels on paper over a few weeks. Records need to be accurate, but this is often difficult because of problems with memory, concentration or low energy and pain. We have recently developed a new technology called ASARM ("Advanced Sleep Rest Activity and Rest Management") that records activity levels electronically and checks whether they match the activity prescription. The ASARM device is worn on the patient's wrist. It measures sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily activities. The health professional has remote access to the information and uses the app to change the prescription. This study will investigate if ASARM is (i) acceptable to patients; (ii) a good way to deliver Cognitive Behavioural therapy CBT treatment; (iii) able to improve their symptoms. Patients and clinicians will gain experience of ASARM for a short time, and we will analyse their data. Our findings will help us develop ASARM so that it can be used in routine care of CFS/ME patients.

NCT ID: NCT02082184 Completed - Clinical trials for Type 2 Diabetes Mellitus

An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes

REPLACE
Start date: March 2014
Phase: N/A
Study type: Interventional

To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.