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NCT ID: NCT03187301 Completed - Parkinson's Disease Clinical Trials

A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes

Start date: August 3, 2017
Phase: Phase 2
Study type: Interventional

A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

NCT ID: NCT03187041 Completed - Clinical trials for Skin Pressures Under Blood Draw-tourniquets

Sensation and Skin Pressures Under Blood-Draw Tourniquets

Start date: December 2016
Phase: N/A
Study type: Interventional

Purpose: This research study seeks to determine whether surface pressures generated by elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues where major arteries and nerves lie. Additionally, investigators will also determine the effects of prolonged tourniquet application on hand sensation using a controlled, reproducible force stimulus. In conjunction, the investigators will also track changes in skin surface pressures and pain levels over this prolonged tourniquet application. Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for blood draws does not significantly impact sensation and will not elicit nerve or tissue damage. Technologies used: Monofilaments and Pressure Sensor

NCT ID: NCT03186859 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)

EDISON
Start date: June 9, 2017
Phase: N/A
Study type: Interventional

Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. It mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure. NAFLD is currently managed by weight loss and treating associated diseases such as diabetes. No medicines have been licensed to directly treat it but bariatric surgery has been shown to be usually beneficial, although it is unknown whether some operations are better than others. It is also unclear whether this is due to general weight loss or other factors. This study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Participants will have ten study visits, four of which may be combined with NHS appointments. Participants will undergo investigations including MRI scans to measure changes in NAFLD and DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be added to allow changes in fat processing to be detected. In addition to samples taken as part of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal)) will be used for research. Visits will take place before and after low calorie diet and bariatric surgery.

NCT ID: NCT03186833 Completed - Clinical trials for Heart Failure With Normal Ejection Fraction

The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.

IDENTIFY-HF
Start date: June 6, 2017
Phase:
Study type: Observational

The study addresses the hypothesis that a gradual build-up in arterial resistance and microvascular endothelial dysfunction due to common comorbidities such as hypertension and diabetes mellitus, on top of age related vascular and cardiac changes (mainly fibrosis and hypertrophy), is responsible for HFpEF. The HFpEF syndrome is commonly seen in elderly subjects (often females) with hypertension and diabetes. The investigators will investigate the vascular function, cardiovascular performance and myocardial fibrosis in different cohorts of subjects to try and prove this hypothesis. There will be 5 groups of subjects, all ≥ 70 years of age, as follows: A) Normal healthy volunteers without major comorbidities including hypertension or diabetes B) Patients with hypertension only (without diabetes mellitus) C) Patients with hypertension AND diabetes mellitus D) Patients with HFpEF. E) A parallel group of patients with Heart Failure with reduced Ejection Fraction (HFrEF) group. Arterial resistance measured by pulse wave velocity will be the primary measure and will be compared between groups A to D. A separate comparison will be made between groups D and E. Other secondary measures will focus on endothelial function (Laser Doppler measurements) and other cardiovascular performance measures (peak VO2 by CPEX, 6-minute walk distance). Bloods samples will be taken for NT-proBNP, high sensitivity Troponin T, Galectin 3 and also stored for testing later for vascular biomarkers.

NCT ID: NCT03186495 Completed - Clinical trials for Adult Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Start date: June 20, 2017
Phase: Phase 1
Study type: Interventional

The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function

NCT ID: NCT03186144 Completed - Clinical trials for Inclusion on Clinical Criteria of the Syndrome

Clinical and Molecular Study of CHARGE Syndrom

CHARGE
Start date: February 2012
Phase: N/A
Study type: Interventional

1. Clinical description of a French cohort of patients with CHARGE syndrome. 2. Search any phenotype-genotype correlation in typical, atypical or incomplete form of the syndrome 3. Using Next generation Sequencing, try to identify other genes involved in this syndrome, as the CHD7 gene is involved in only 40-60% of cases

NCT ID: NCT03185962 Completed - Clinical trials for Mechanical Ventilation

Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study

POSE
Start date: May 1, 2017
Phase:
Study type: Observational

Extubation failure can directly worsen patient outcomes. Therefore, the decision to extubate is a critical moment during an intensive care unit (ICU) stay. The decision to extubate is usually made after a weaning readiness test involving spontaneous breathing on a T-piece or low levels of ventilatory assistance. However, extubation failure still occurs in 10 to 20% of patients. The investigators focused on previously reported physiological risk factors, and were able to obtain from common clinical practice: 1) age, 2) underlying cardiovascular disease, 3) underlying respiratory disease or occurrence of pneumonia, 4) rapid shallow breathing index (RSBI), 5) positive fluid balance during the previous 24 hours, 6) the ratio of arterial oxygen partial pressure to fractional inspired oxygen, 7) Glasgow Coma Scale, 8) respiratory tract secretions. The investigators aimed to assess the incidence and risk factors for extubation failure among critically ill patients who passed the 30 min spontaneous breathing test (SBT) using a low level of pressure support (PS) with positive end-expiratory pressure (PEEP), in a prospective multicenter study.

NCT ID: NCT03185598 Completed - Clinical trials for Major Adverse Cardiac-cerebral-kidney Event

MACE and First Operating Room Systolic Blood Pressure in Patients Undergoing Non-cardiac Surgery Implications for the Hypertension Threshold

Start date: January 1, 2016
Phase:
Study type: Observational

To find the threshold of First operating room SBP above which MACE risk increases.

NCT ID: NCT03185520 Completed - Clinical trials for Embolic Stroke of Undetermined Source

Young ESUS Patient Registry

Y-ESUS
Start date: February 15, 2017
Phase:
Study type: Observational [Patient Registry]

This study seeks to determine the clinical characteristics of young ESUS patients using diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to determine the rates of stroke recurrence, death, and hospital readmission in a contemporary cohort of young ESUS patients during follow-up of up to 18 months.

NCT ID: NCT03185013 Completed - Cervical Dysplasia Clinical Trials

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

REVEAL 1
Start date: June 28, 2017
Phase: Phase 3
Study type: Interventional

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.