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NCT ID: NCT02618291 Completed - Geriatric Syndrome Clinical Trials

Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family Medicine

AGE3
Start date: June 2016
Phase: N/A
Study type: Interventional

This study aims to test the efficacy of a comprehensive assessment and management tool (AGE: Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly patients followed in family medicine. Family practitioners will be randomised either to the intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a management plan in case of positive screening, or to usual care. Level of functioning and quality of life of patients in both arms will be assessed over two years.

NCT ID: NCT02617589 Completed - Brain Cancer Clinical Trials

An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

CheckMate 498
Start date: March 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

NCT ID: NCT02615847 Completed - Sickle Cell Disease Clinical Trials

Clinical Trial to Study the Safety and Tolerability of Memantin Mepha® in Sickle Cell Disease Patients

MemSID
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Symptomatic sickle cell disease is worldwide the most frequent cause for hereditary hemolytic anemia with recurrent pain crisis. Hemolysis, vaso- occlusive and pain crises are hallmarks of this disease and are causative for an important socio-economic burden worldwide, especially in Africa. Aside from allogenic stem cell transplantation, which is rarely available and very expensive, at present there is no curative treatment for patients with sickle cell disease (SCD). The current standard of care includes treatment with hydroxycarbamide and symptomatic care such as transfusions, antibiotic/analgesic treatment. This study has the aim to study the safety and tolerability of Memantin in patients with sickle cell disease.

NCT ID: NCT02615249 Completed - Clinical trials for Dermatitis, Eczematous

Clinical Evaluation of Metal Panel Allergens: Dose Response Study

Start date: December 5, 2016
Phase: Phase 2
Study type: Interventional

48-hour application of metal allergen patches to test for potential allergic responses.

NCT ID: NCT02614794 Completed - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

HER2CLIMB
Start date: January 28, 2016
Phase: Phase 2
Study type: Interventional

This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

NCT ID: NCT02614313 Completed - Clinical trials for Irritable Bowel Syndrome

Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

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

Background: Breath testing for food intolerances is becoming routine in patients with functional gastrointestinal disorders (FGID). Both FGID and saccharide intolerances (FODMAPs: fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose, sorbitol) are common (>10% of any given population) and often respond to dietary modification. The breath tests are based on quantification of gas excretion in breath as a sign of malabsorption and symptom provocation, but are likely subject to considerable psychological bias. The role of expectation and other psychological effects on breath testing has not been reported, but is crucial for the validation of these increasingly wide-spread tests with considerable dietary and potentially deleterious consequences. Fructose has been shown to result in short term pro-inflammatory metabolic responses, but these effects have not been studied as underlying causes for intolerance symptoms in fructose intolerant patients with FGID. Aim: To investigate the psychological component and the short-term metabolic effects of fructose breath testing in patients referred for evaluation of FGID using placebo. Additionally, to assess baseline predictors for a positive breath test result. Methods: Fructose intolerance (defined by a positive symptom index) and malabsorption (defined by increased breath hydrogen/methane concentrations) will be determined in 30 successive male and female FGID in a single centre using breath-testing. Fructose 35g, given double-blind as well as open, a sweet placebo (cyclamate/saccharine; Assugrin®) and a neutral (still water) placebo given double-blind will be compared in a randomized, cross-over sequence and according to our standardised procedure on four separate study days. Symptoms will be recorded using standardised questionnaires and breath concentrations of H2 and CH4 will be measured during testing on the four study days. Somatisation and psychological profiles will be assessed by questionnaires. Blood samples will be obtained before and during provocation testing to assess short-term responses to fructose loading by metabolomics. Fructose, blinded and open, and placebo responses will be compared and baseline predictors for a positive breath tests assessed.

NCT ID: NCT02613845 Completed - Clinical trials for Postoperative Delirium

Predictors for Postoperative Delirium After Cardiac Surgery in Adults: a One-year, Single Center, Observational Cohort Study

PODCAS
Start date: January 1, 2013
Phase:
Study type: Observational

The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment)". In addition, a "disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception)" occurs. Postoperative delirium (POD) usually develops in connection with a surgical procedure within the first five days after an intervention. Roughly 10-70% of all surgical patients above the age of 65 years are affected. POD places not only a burden to the patient and their families by increasing functional and cognitive damages, and increasing mortality, it also has a high impact on the health care resource utilization. A patient with POD often requires more intensive care, has a longer length of hospital stay, more complications, and often requires long-term care after being discharged from the hospital. All these aspects show the need for prevention of POD. There are various preoperative risk factors that influence the development of POD. Broad research has been done on this topic and shown that advanced age, cognitive impairment, depression and other psychopathologic symptoms, intake of psychotropic substances, sensory impairment like decrease in visual or auditory perception, impairment in daily life activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severity of disease and different comorbidities, such as chronic cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections may favor the occurrence of POD. The incidence of POD is among the highest in cardiac surgery. The study was designed to assess predictors for POD after cardiac surgery. Study hypothesis is that some patient variables, scores and biomarkers are not only predictive of the incidence of POD but also of the severity of delirium-associated symptoms and duration of POD after cardiac surgery.

NCT ID: NCT02612870 Not yet recruiting - Breast Neoplasms Clinical Trials

Sienna+® Injection Time Study 4 Arms

Sentimag02
Start date: February 2016
Phase: Phase 4
Study type: Interventional

Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.

NCT ID: NCT02612597 Recruiting - Healthy Clinical Trials

The Effect of Blood Volume Changes on the Glucose Tolerance

BV-GT
Start date: January 2015
Phase: N/A
Study type: Interventional

In this study the investigators would like to elaborate on the mechanisms that lead to a higher insulin sensitivity after exercise training and a lower insulin sensitivity after bedrest. The investigators speculate that the concomitant chances in blood volume during training and bedrest might explain the changed insulin sensitivity because with a changing blood volume also the dilution space of the glucose will change. Furthermore, the investigators would like to work on the influence of a changed capacity of skeletal muscle for glucose uptake and glycogen storage on the glucose sensitivity. Therefore, A) a bed rest study with healthy untrained subjects and B) a training study with obese pre-diabetic patients will be conducted.

NCT ID: NCT02612129 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C

Arimoclomol Prospective Study in Participants Diagnosed With Niemann-Pick Disease Type C

Start date: June 14, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

A prospective, randomized, double-blind, placebo controlled therapeutic study in participants with confirmed diagnosis of Niemann-Pick disease type C (NPC). The purpose of this study is to assess the efficacy and safety of arimoclomol (compared to placebo) when it is administered as an add-on therapy to the participant's current prescribed best routine clinical care; participant's routine clinical care may, or may not, include miglustat. The CT-ORZY-NPC-002 study has been expanded to include an open label paediatric sub-study including participants aged 6 to <24 months at study enrolment.