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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: NCT02520921 Active, not recruiting - Obesity Clinical Trials

Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome

ANDAMAN
Start date: June 13, 2016
Phase: Phase 4
Study type: Interventional

To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.

NCT ID: NCT02520908 Active, not recruiting - Clinical trials for Epidermotropic T-cell Lymphomas

Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis

CUTALLO
Start date: September 23, 2016
Phase:
Study type: Observational

Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).

NCT ID: NCT02518763 Active, not recruiting - Osteoporosis Clinical Trials

Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

VITAD
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis

NCT ID: NCT02517892 Active, not recruiting - Clinical trials for Metastatic Oncogen-driven Cancer

A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

MATCH-R
Start date: December 18, 2014
Phase: N/A
Study type: Interventional

This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer. This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.

NCT ID: NCT02517125 Active, not recruiting - Clinical trials for Head and Neck Cancer

Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors

TORS
Start date: April 2015
Phase: N/A
Study type: Interventional

Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci. The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The objective of our study is therefore to study the feasibility of this transoral robotic surgery for head and neck cancers, using the da Vinci Xi.

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: NCT02514278 Active, not recruiting - Rectal Cancer Clinical Trials

Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

GRECCAR12
Start date: January 28, 2016
Phase: Phase 3
Study type: Interventional

Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes. The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.

NCT ID: NCT02511106 Active, not recruiting - Clinical trials for Stage IB-IIIA Non-small Cell Lung Carcinoma

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

ADAURA
Start date: October 21, 2015
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

NCT ID: NCT02510560 Active, not recruiting - Clinical trials for Premature Birth of Newborn

Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Start date: December 2016
Phase: Phase 3
Study type: Interventional

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.