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NCT ID: NCT03727750 Completed - Pharmacokinetics Clinical Trials

Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

Start date: July 3, 2019
Phase: Phase 4
Study type: Interventional

This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.

NCT ID: NCT03727386 Completed - Clinical trials for Cognitive Impairments, Mild

The Effect of Vegetable Oil on Cognitive Functions of MCI Patients

DICe
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

This study explores the feasibility of applying an intervention using vegetable oils (coconut and sunflower oils) on individuals diagnosed with Mild Cognitive Impairment. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months.

NCT ID: NCT03726567 Completed - Obesity Clinical Trials

Environmental Chemicals That Accumulate in Fat

Start date: October 12, 2012
Phase: N/A
Study type: Interventional

A crucial factor in evaluating the risk of dioxins, and related endocrine disruptor compounds (dioxins for short) in the human population is the accumulation of these chemicals in the human body. Human data on tissue background levels is extremely limited, and there are no studies in UK populations, although there are several European studies looking at blood levels of dioxins. Adipose tissue concentrations were 139 ng of TEQ (total dioxin-like compounds) per kg lipid weight (5.4 ± 4.6 ng of TCDD per kg lipid weight). However, given the different dietary habits of Japanese populations, compared to European populations, these estimates may differ considerably from UK values. Thus determining human tissue concentrations of dioxins is an important issue for assessing the risk to public health from these compounds, and this information is currently lacking for European populations. This information will also guide and inform the necessity fro continued measures to reduce the environmental dioxin levels in the UK. Aims Primary outcomes: 1. Investigation of the toxicodynamics of/dioxin distribution in adipose of a morbidly obese and comparative control population 2. Characterisation of the burden of dioxins in liver and adipose tissue, and the relationship with blood levels of dioxins, in a UK population Secondary outcome: Determining whether bariatric surgery-induced weight loss causes an increase in tissue concentration of dioxin-like compounds The primary aims of this study will yield useful information to refine the risk assessment process for the obese population. Experimental Methodology This proposal seeks to examine thirty non-obese patients taking liver (500mg) and adipose tissue (visceral and subcutaneous: 40g each) samples at the time of gastric/abdominal surgery; and thirty obese patients, taking liver (500mg) and adipose tissue (visceral and subcutaneous: 40g each) samples at the time of undertaking Roux -en-y bariatric surgery. Weight and bioimpedance and a food diary will be performed prior to surgery. A further body weight and bioimpedance will be undertaken at 3, 6, 9 and 12 months from the obese population. A subcutaneous adipose biopsy will be taken under local anaesthetic from these individuals at after bariatric surgery (minimum of 10% body weight loss). A record of weight loss since bariatric surgery will documented with the change in body composition. The statistical power for seeing an effect of gastroplasty, assuming a coefficient of variation of TEQ measurements of 75% and an increase in TEQ of two-fold, is 90% at P<0.05 for a population of thirty individuals. Should subjects need additional surgery (eg. cholecystectomy, diagnostic laproscopy) either as a consequence of bariatric surgery or for any other reasons during the 24 month following initial operation, a liver biopsy and visceral fat biopsy will be taken during the future surgery. If subjects undergo abdominal wall surgeries (eg. Apronectomy, ventral hernia repair) in the 24 months following initial bariatric surgery, an subcutaneous fat biopsy will be taken during the future surgery.

NCT ID: NCT03725150 Completed - Clinical trials for Anemia, Iron Deficiency

Treatment of Iron Deficiency Anaemia in Pregnancy Study

TIAP
Start date: June 19, 2018
Phase:
Study type: Observational

The burden of anaemia remains unacceptably high during pregnancy. Over a third of women are anaemic by their third trimester of pregnancy. The most common cause is iron deficiency. One key factor is rising iron requirements throughout pregnancy. There are risks associated with anaemia for the mother and infant. Anaemia in the first and second trimester has been significantly correlated with low birth weight and pre-term birth, and is associated with impaired neurological development of the baby. It also increases the risk of intrauterine fetal death, and the likelihood of the mother requiring blood transfusions during or after delivery.This study is a prospective cohort study, which aims to better define the natural history and understand how to use oral iron therapy for iron deficiency anaemia in pregnant women. This includes documenting the impact of treatment on anaemia symptoms, side effects, and the level of success of iron therapy using several haematological tests. Pregnant women will be invited to participate in this study and treated using a treatment schedule as described in national guidelines. Additional blood samples will be taken for subsequent detailed analysis of pathways of iron metabolism to better predict the response to oral iron therapy during pregnancy.

NCT ID: NCT03725124 Completed - Clinical trials for Inflammatory Bowel Diseases

Family Planning in Inflammatory Bowel Disease

Start date: July 26, 2018
Phase:
Study type: Observational

This study explores the lived experiences of family planning for women with inflammatory bowel disease (IBD) and their partners during the reproductive stages of pre-conception, pregnancy and the postnatal period through qualitative interviews. Insights from existing literature alongside findings from interviews and focus groups with patients and healthcare providers to develop an intervention to address the issues and support needs as identified by study participants.

NCT ID: NCT03724877 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effectiveness of Triple Therapy in COPD

Start date: November 10, 2018
Phase:
Study type: Observational

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.

NCT ID: NCT03724812 Completed - Clinical trials for Symptomatic Severe Aortic Stenosis

FlexNav EU CE Mark Study

Start date: February 26, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

NCT ID: NCT03723265 Completed - Heart Failure Clinical Trials

Personalized CRT - PSR

Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

NCT ID: NCT03721107 Completed - Clinical trials for Irritable Bowel Syndrome

A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome

Start date: October 11, 2018
Phase: Phase 2
Study type: Interventional

A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).

NCT ID: NCT03721016 Completed - Glabellar Lines Clinical Trials

MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

Start date: October 26, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.