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NCT ID: NCT03235557 Recruiting - Prostate Cancer Clinical Trials

CyberKnife for Prostate Cancer Patients Aged 70 y or More

ProRobot
Start date: October 2014
Phase: N/A
Study type: Observational [Patient Registry]

Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly. Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) <30ng/ml. Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores>5. Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.

NCT ID: NCT03210129 Not yet recruiting - Endometrial Cancer Clinical Trials

Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients

MIPAClux
Start date: July 6, 2017
Phase: N/A
Study type: Interventional

Physical activity is not only efficient for primary prevention of several cancer types, but it also plays an important role in cancer survivors. Physical activity after a cancer diagnosis has been associated with reduced overall and cancer-specific mortality. It has significant positive effects on physical fitness and several cancer-related symptoms including fatigue, sleep disturbance, depression and anxiety. The evidence is considerable and consistent for breast, colorectal and endometrial cancers. However, patients are generally insufficiently active, and participation rates in physical activity opportunities offered by specialized organizations are low. This pilot study will evaluate the feasibility, efficacy and cost-effectiveness of an intervention seeking to increase active lifestyle and physical activity participation of cancer patients. To encourage this behavioural change, motivational interviewing will be used, a patient-centred approach aimed at increasing the patients' motivation for a behavioural change through open-ended discussions. Seventy patients with breast, colorectal or endometrial cancer will be recruited within a time period of 12 months. Patients will be randomly assigned to an intervention or a control group. The intervention group will receive standard care alongside 12 motivational interviewing sessions within 12 weeks. The control group will receive standard care only. Physical activity behaviour (3D-accelerometer) and physical fitness (cardiovascular and strength fitness) will be measured in the week preceding and following the intervention. Additionally, a subgroup from both study arms will be assessed 12 weeks after the completion of the intervention. The investigators hypothesize that sedentary time will decrease and time spent in moderate and vigorous physical activity, physical fitness and quality of life of cancer survivors will increase to a greater extent in the intervention group than in the control group. Furthermore, health-related quality of life and resource use (intervention and healthcare costs, out of pocket costs) will be measured to evaluate the cost-effectiveness of the intervention.

NCT ID: NCT03209128 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala

IPC
Start date: April 20, 2017
Phase: N/A
Study type: Observational

Hippocampus and amygdala are parts of the brain involved in the recognition of emotions, memories, memory, language ... It is therefore very important to protect them during irradiation of the brain. The aim of this study is to evaluate cerebral irradiation with saving hippocampus and amygdala protects these brain functions in patients with small cell lung cancer (SCLC) Radiotherapy of the brain

NCT ID: NCT03206385 Recruiting - Pelvis Tumors Clinical Trials

IMRT Followed by CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume

Boost_Pelvis
Start date: May 31, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The present register has been designed to confirm the hypothesis that while using high quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy could not be proposed as a boost.

NCT ID: NCT03199144 Recruiting - Clinical trials for Pancreatic Neoplasms

Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer

CKPancreas
Start date: April 20, 2017
Phase: Phase 2
Study type: Interventional

The goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described.

NCT ID: NCT03191786 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for platinum-containing therapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

NCT ID: NCT03115437 Not yet recruiting - Clinical trials for Running-Related Injury (First-time)

Effects of Shoe Cushioning and Body Mass on Injury Risk in Running

RRI_Interv4
Start date: September 13, 2017
Phase: N/A
Study type: Interventional

The main goal is to investigate the influence of shoe cushioning and body mass on the risk of running-related injury. This study will allow to determine if shoe cushioning needs to be adapted to the mass of the runner in order to minimize injury risk. The influence of shoe cushioning on running technique will also be investigated. This study consists in a 6-month follow-up period during which leisure-time runners are required to perform a running activity at least once a week and to upload all their running as well as other sporting activities onto a secured web-based training calendar named "Training and Injury Prevention Platform for Sports" (TIPPS) on a weekly basis. Any injury sustained during this period should also be uploaded onto the TIPPS system using the injury questionnaire provided on the website. Finally, the day of the visit to the laboratory (study start), their running style will be analysed during a 15-minute run on an instrumented treadmill at the participant's usual running speed. Anthropometric measurements will also taken. Before the beginning of the study, the participants will receive a pair of running shoes free of charge. These shoes will either have a soft or hard sole. Both shoe versions have cushioning properties that correspond to the range of values from the shoes available on the market. They will be administered through random allocation. Neither the participants nor the research team will know which shoe version was provided to the participant, in order to respect the double-blinded methodology of this study. The participants will be required to use these shoes for all running sessions, and only for running activities. Hypotheses: H1: Running shoes with greater stiffness are associated with a higher injury risk in leisure-time runners. H2: High body mass is associated with a higher injury risk in leisure-time runners. H3: Runners with a high body mass experience a lower injury risk in shoes with greater stiffness. H4: A higher step length, a lower step frequency, and higher peak vertical impact forces are associated with a higher injury risk. H5: Running shoes with greater stiffness will be associated with higher vertical impact peak forces and a shorter contact time. H6: High body mass will be associated with higher peak vertical impact forces, increased contact time, increased duty factor, and decreased step frequency.

NCT ID: NCT03103867 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

QUality of Control and slEep in Children With diabeteS, Using New Technology

QUEST
Start date: February 23, 2017
Phase: N/A
Study type: Interventional

The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.

NCT ID: NCT03101865 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

The Artificial Pancreas in Very Young Children With T1D - Pilot (KidsAP01)

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme. The project evaluates the use of the Artificial Pancreas (or closed loop systems) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is a feasibility study to pilot the setup of a large-scale outcome trial and to address the specific needs of this population. The results of the pilot trial will feed into the design of the outcome study. In this study the investigators will compare closed loop insulin delivery using standard strength insulin to closed loop use with diluted insulin in very young children with T1D. Diluted insulin is a standard treatment approach for children with low insulin requirements. The investigators hypothesize that diluted insulin will lead to more stable glucose levels by reducing inaccuracies accentuated by delivery of minute amounts of insulin (frequently less than 0.1U/h [1μl/h with standard strength insulin] in small children compared to 1U/h in adults). These inaccuracies may result from pump plunger micro-jumps, tissues pressure build-up, and infusion set kinking. This study builds on previous and on-going studies of closed loop systems that have been performed in Cambridge in children and adolescents with T1D in clinical research facilities and in the home setting. The study adopts an open-label, multi-centre, multinational, randomised, two-period crossover design contrasting closed loop glucose control using diluted insulin and closed loop using standard insulin strength under free-living home conditions. The two intervention periods will last 3 weeks each with a 1 to 4 weeks washout period in between. The order of the two interventions will be random. A total of up to 30 young children aged 1 to 7 years with T1D on insulin pump therapy will be recruited through outpatient diabetes clinics at participating clinical centres to allow for 24 completed subjects available for assessment in each of the study arms. Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and continuous glucose monitoring system, and the hybrid closed loop insulin delivery system. Carers at nursery or school may also receive training by the study team if required. During the intervention periods, subjects and parents/guardians will use the closed loop system for 21 days under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/l as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.

NCT ID: NCT03052309 Recruiting - Clinical trials for Peripheral Arterial Disease

BIOLUX P-III BENELUX All-Comers Registry

Start date: February 27, 2017
Phase: N/A
Study type: Observational

The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries