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NCT ID: NCT02551120 Active, not recruiting - Clinical trials for Pseudohypoparathyroidism

Characterization of Patients With Non-surgical Hypoparathyroidism and Pseudohypoparathyroidism

Start date: June 2014
Phase:
Study type: Observational

Hypoparathyroidism (hypoPT) and pseudohypoparathyroidism (Ps-hypoPT) are rare diseases, characterized by low levels of parathyroid hormone [PTH] and plasma calcium or high plasma PTH and low plasma calcium, respectively. A recently study by the investigators' group, identified 123 living persons with idiopathic hypoPT and 62 living persons with Ps-hypoPT, only few of these have been genetic tested. The aim of the study is to perform a detailed clinical and genetic characterization of Danish patients with idiopathic hypoPT and Ps-hypoPT. Patients will be examined by questionnaires, biochemistry, scans, bone biopsies and genetic tests. Furthermore the investigators aim to perform family tracing for the hereditary forms. The prevalence of magnesium depletion will be assessed as well. In addition to providing new information on symptoms, co-morbidity, and prognosis for this group of patients, the investigators presume that the study may improve their understanding on calcium homeostasis and bone metabolism in general.

NCT ID: NCT02542293 Active, not recruiting - Clinical trials for Non Small Cell Lung Carcinoma NSCLC

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

NEPTUNE
Start date: November 3, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

NCT ID: NCT02541292 Active, not recruiting - Clinical trials for Facioscapulohumeral Muscular Dystrophy 1a

Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Start date: February 2016
Phase:
Study type: Observational

Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs. The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD. Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.

NCT ID: NCT02540252 Active, not recruiting - Inflammation Clinical Trials

Nutrition and Inflammation Among Patients With Lower Limb Amputation

Amp-Nu
Start date: August 19, 2015
Phase: N/A
Study type: Observational

Patients with non-traumatic lower limb amputation are characterized by; high age; majority being men; multimorbidity; and high mortality. The patients comorbidities are related to diabetes and cardiovascular disorders such as arteriosclerosis. Major surgery induces a surgical stress response that initiates a catabolic metabolism. Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and after amputation is high (3) as the most prominent indication for amputation is gangrene, followed by non-healing or infected wounds. This leads to an impaired immune response and an increased insulin resistance that also includes a cascade of impaired appetite regulation, low dietary intake and reduced nutrient uptake form the intestine which increases inflammation, loss of muscle and risk of severe complications. Among healthy adults with a normal weight a slow speed of eating will result in a low nutritional intake due to faster satiety experience. Low appetite following major surgery is related to the regulation of hormone controlling the appetite. Especially older patients experience variations in appetite that affect their eating pattern such as eating speed and intake. It is therefore reasonable to assume that the speed of eating and the total nutritional intake among older patients, who are exposed to catabolic metabolism, are associated. The hypothesis is that major surgery induces a change in patients' current eating pattern that is measurable and can be identified as a surrogate measurement of the catabolic state that is related to inflammation. Eating Patterns are often described in clinical practice without engaging in nutritional assessment of the patient. Whether the speed of eating is an objective marker of the current nutritional status has not been established. This study investigates patients undergoing lower limb amputation and their nutritional status, eating pattern and inflammation and whether this is linked to the current degree of disease. The purpose is to describe the development in nutritional status before and after amputation and to investigate associations between patients eating pattern and nutritional status to inflammatory and metabolic biomarkers reflecting the degree of disease.

NCT ID: NCT02539966 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

FANTOM II
Start date: March 2015
Phase: N/A
Study type: Interventional

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

NCT ID: NCT02536118 Active, not recruiting - Bradycardia Clinical Trials

Micra Transcatheter Pacing System Post-Approval Registry

Start date: July 2015
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release. The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

NCT ID: NCT02522390 Active, not recruiting - Health Clinical Trials

The Nutrition Researcher Cohort 2014 Study

NRC250
Start date: January 2015
Phase: N/A
Study type: Observational

The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop and evaluate the open access Nutrition Researcher Cohort for gathering personal health data from nutrition researchers, including analytical methods, standards and operation procedures, data infrastructure, ethical and privacy aspects, and governance. Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound intake and exposure, biomarkers for food, health and/or disease and health and/or disease related measurements to study the relation between nutrition, health and development of disease (on individual level). In addition, data will be used to develop applications that visualise personal health risks based for example on (validated) recommendations and applications that predict individual health risks. The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort will be composed of about 250 life sciences employees and students from different, predominantly European, countries. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male and female scientists per participating country.

NCT ID: NCT02518269 Active, not recruiting - Pain Clinical Trials

A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

Start date: May 4, 2015
Phase: N/A
Study type: Interventional

The study is designed to compare three articulation options in terms of osteolysis, patient satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score (HHS) and safety. In addition, the purpose of the study is also to evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary total hip arthroplasty.

NCT ID: NCT02516241 Active, not recruiting - Urothelial Cancer Clinical Trials

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Start date: November 2, 2015
Phase: Phase 3
Study type: Interventional

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

NCT ID: NCT02505750 Active, not recruiting - Rectal Neoplasms Clinical Trials

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

OPERA
Start date: June 24, 2015
Phase: Phase 3
Study type: Interventional

The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery. The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%). Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma. Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.