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NCT ID: NCT02846857 Withdrawn - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes

Start date: n/a
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon. The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults. The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.

NCT ID: NCT02847013 Withdrawn - Pain Clinical Trials

The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.

NCT ID: NCT02870647 Withdrawn - Clinical trials for Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients

SYNCHRO
Start date: n/a
Phase: Phase 4
Study type: Interventional

Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.

NCT ID: NCT02891746 Withdrawn - Microbiota Clinical Trials

Maternal and Neonatal Microbiome

Start date: n/a
Phase: N/A
Study type: Observational

The aim of the study is to characterize and monitor the microbiome of premature infants born in the investigators facility until discharge from the NICU. The investigators will also examine the relationship between mode of delivery and the microbiome of the infant, while exploring various possible factors that may affect it. In addition, the investigators will compare the microbiome of premature infants to the microbiome of term babies born at the same time in the same facility.

NCT ID: NCT02909634 Withdrawn - Ostomy Clinical Trials

Combining Ostom-I With Abstats Sensors to Improve Prediction of Ostomy Output

Start date: n/a
Phase:
Study type: Observational

Currently, the number of patients having either permanent or temporary stomas placed is increasing each year. Yet, patients with ostomy pouches often struggle with predicting when stool output will occur and how to plan around dynamic changes in intestinal activity. Ostom-I provides a real-time assessment of the volume in the ostomy bag, it does not predict when and how fast such output will occur. In this pilot study the investigators aim to gather normative AbStats and Ostom-I data in participants with an ostomy to improve prediction of stool output. Aim 1: To gather normative AbStats and Ostom-I data in subjects with an ostomy to improve prediction of stool output. Aim 2: Correlate the data from both wearable biosensors and test the predictive validity of AbStats in determining ostomy bag filling as measured by Ostom-I.

NCT ID: NCT02918708 Withdrawn - Vaccination Clinical Trials

Assessment of Novel Pneumococcal Conjugate Vaccination Scheduled in UK Infants

PINC
Start date: n/a
Phase: Phase 4
Study type: Interventional

The National Vaccine Evaluation Consortium conducts Department of Health funded trials trials to provide information to underpin changes to the national immunisation and vaccination schedule. This study will assess how different schedules of pneumococcal conjugate vaccines work in providing protection to young infants. It is well established that vaccines can behave differently depending on which order they are given and alongside which other immunisations. This has been shown for Hib and MenC vaccines, which are similar in structure to the pneumococcal vaccines that will be studied here. The investigators will measure responses to the pneumococcal vaccines as well as to other routine immunisations, all of which will be provided by our study team. Infants will be recruited by dedicated study staff through primary care and will participate from their first vaccinations at 2 months of age, until the blood sample taken a month after their boosters at a year old, i.e. until 13 months of age. Any child found to have antibody levels below that which indicates protection for Hib, MenC, MenB or pneumococcal in the blood sample taken at 13 months of age will be offered an extra dose of the relevant vaccine(s).

NCT ID: NCT02930811 Withdrawn - Clinical trials for Peripheral Arterial Occlusive Disease

Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication

VALSTAR
Start date: n/a
Phase: Phase 3
Study type: Interventional

Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD. Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication. For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).

NCT ID: NCT02931448 Withdrawn - Clinical trials for Carbon Monoxide Poisoning

Occult Carbon Monoxide Poisoning Detection by Pulsated Carboxymetry in an Emergency Department

MAS-CO
Start date: n/a
Phase:
Study type: Observational

In France, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths. The severe forms are translated by neurological disorders even a coma or the death straight away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its appearance and its gravity are not correlated in the gravity of the initial poisoning, however the precocity of the treatment tends to decrease its frequency. Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes. This imposes a fast diagnosis for two reasons: - For poisonings with low level, the more the investigators wait to measure the carboxyhémoglobine (HBCO), the more they risk not to detect it. - The oxygen therapy decreases the duration of the poisoning and thus the tissular suffering. Actually the risk is important to pass next to the diagnosis and to let leave a patient without adapted care and without technical intervention to eliminate the source of the poisoning. Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by realization of gas of the venous blood, which are taken in emergencies, but very often a few hours after the end of the exposure at the source of poisoning, what is translated by a disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005, MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate the carboxyhémoglobinémie in a not invasive way. Lot of studies showed the interest of its use in the early screening of carbon monoxide poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.

NCT ID: NCT02934373 Withdrawn - Hearing Loss Clinical Trials

Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products

Start date: n/a
Phase: N/A
Study type: Interventional

Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System

NCT ID: NCT02950688 Withdrawn - Influenza, Human Clinical Trials

Safety and Effectiveness of a Seasonal Live Attenuated Influenza Vaccine in a Human Challenge Model of Infection With Wild-type (wt) Influenza A/California/2009 (H1N1)-Like Virus

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the immune response produced by a seasonal live attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical response, and viral shedding after exposure to the wild-type A/California/2009-like influenza challenge virus.