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NCT ID: NCT01732653 Completed - Parkinson Clinical Trials

A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults

VTIME
Start date: November 2012
Phase: N/A
Study type: Interventional

The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk. 300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.

NCT ID: NCT01732419 Completed - Clinical trials for Myocardial Infarction

Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation

FIT@Home
Start date: January 2013
Phase: N/A
Study type: Interventional

Physical exercise training appears effective for low to moderate patients assigned to cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity levels often drop after attending the last supervised rehabilitation session. This study will compare home based physical exercise training including telemonitoring with regular centre based physical exercise training. Main outcome measures are the change in physical activity and the change in physical fitness (peak Oxygen uptake) after the initial rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are cost-effectiveness, training adherence, health-related quality of life and patient satisfaction.

NCT ID: NCT01731379 Completed - Clinical trials for Colon Rectal Cancer Tubulovillous Adenocarcinoma

Optical Detection of Peripheral Nerve Bundles During Surgery

NerveSpect
Start date: December 2012
Phase: N/A
Study type: Observational

Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

NCT ID: NCT01730664 Completed - Clinical trials for PK of Ertapenem in TB Patients

PK/PD of Ertapenem In Patients With TB

Start date: January 26, 2017
Phase: Phase 2
Study type: Interventional

Rationale: Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. New, more effective drugs with less side effects are therefore urgently needed to solve this problem. Although several new drugs against TB are in the pipeline, physicians currently have limited treatment options for treatment of complicated MDR/XDR-TB cases. Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB. Objective: The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a standard dose (2000mg) of ertapenem in TB patients. This clinical trial will provide important information on PK of ertapenem in TB patients for future studies. Data can be used for limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients. Study design: A prospective pharmacokinetic study. Study population: 12 TB patients. Intervention: Single dose of 2000mg in a 30 minutes intravenous infusion. Main study parameters/endpoints: The pharmacokinetic parameters (Vd, Cl, AUC, etc) of ertapenem are the primary endpoints of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most likely the best predictive parameters for efficacy of ertapenem treatment and will be calculated for a range of M tuberculosis isolates.

NCT ID: NCT01730534 Completed - Clinical trials for Diabetes Mellitus, Non-Insulin-Dependent

Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

DECLARE-TIMI58
Start date: April 25, 2013
Phase: Phase 3
Study type: Interventional

This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

NCT ID: NCT01730365 Completed - Breast Cancer Clinical Trials

Optical Detection of Malignancy During Percutaneous Interventions

Start date: October 2012
Phase: N/A
Study type: Observational

Investigation of application possibilities of optical spectroscopy within the field of oncology. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignancies.

NCT ID: NCT01728805 Completed - Clinical trials for Cutaneous T-Cell Lymphoma

Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

NCT ID: NCT01728701 Completed - Malaria Clinical Trials

Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).

NCT ID: NCT01728493 Completed - Clinical trials for Primary Aldosteronism

Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment

PAGODE
Start date: September 2013
Phase: N/A
Study type: Observational

Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99% predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). Diagnosis of PA is relevant for two reasons: 1. independent of the level of blood pressure, hypertension due to autonomous aldosterone secretion causes more cardiovascular damage than essential hypertension; 2. PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists (MRA) in case of BAH. Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the amount of cardiovascular damage and the available specific treatment, the question is raised whether screening of PA should be introduced in Dutch general practice. To answer this important question, several issues with regard to PA need to be elucidated: 1. International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown; 2. Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of hypertension (mean eight years), data on characteristics of early diagnosed PA are lacking. Proof of early cardiovascular damage would strengthen the case of screening for PA and needs to be studied; 3. Consequently, the diagnostic delay has lead to lack of data on optimal treatment in early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a regimen of antihypertensive drugs is advised, and only if hypertension is refractory for >6 months patients are referred. It is unknown if hypertension is resistant to therapy in the initial phase of PA. If not, this would also argue for early biochemical screening for PA, because even if blood pressure is controlled, the detrimental effect of aldosterone itself will go on unopposed. It is therefore required to study the response to antihypertensive drugs (not MRA) in these patients.

NCT ID: NCT01727895 Completed - Clinical trials for Immunologic Deficiency Syndromes

Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans

BG
Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.