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NCT ID: NCT00840359 Enrolling by invitation - Clinical trials for Cutaneous Leishmaniasis

Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The aim of the project is to determine whether daylight activated photodynamic therapy is effective in treating cutaneous leishmaniasis caused by L. major and L. tropical. PDT is classically performed as a two-step procedure in which MAL application to the lesion constitutes the first step, and PpIX activation by light of appropriate wavelength from an artificial light source constitutes the second step. Based on the knowledge that red and blue light required to activate PpIX are part of the daylight spectrum, the investigators postulated that effective PpIX activation can be obtained by exposure of the MAL treated lesions to daylight thus substantially simplifying the PDT procedure by omitting the 3 hour incubation period and the subsequent exposure to artificial light. In accord, in a recent study the investigators showed that daylight-activated PDT (DA-PDT) was as effective as conventional MAL-PDT in treating precancerous actinic keratoses lesion. Furthermore the investigators found that DA-PDT is significantly less painful than conventional MAL-PDT. The investigators now propose to study the efficacy of DA-PDT in the treatment of cutaneous leishmaniasis. DA-PDT has obvious advantages to conventional leishmania treatment forms: As opposed to most of the available treatment options, DA-PDT is a self-administered procedure that does not require the assistance of medical personnel. Secondly, judged by our experience with MAL-PDT, only few treatment sessions are required for effective parasite killing as opposed to the prolonged procedures usually required for treatment of leishmaniasis. Third, PDT has the far the best safety profile of all available treatment options.

NCT ID: NCT00840125 Completed - Clinical trials for Non-Small Cell Lung Cancer

Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment

Start date: February 2009
Phase: Phase 2
Study type: Interventional

Study Rationale: There is increasing evidence that erlotinib improves overall survival in selected patients with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a potential for synergism between erlotinib and docetaxel. This study will further evaluate the effects of combination treatment on overall survival in selected NSCLC patient population. Based on recent published data, the treatment cycle in this study will be 22 days with two infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to be just as effective as the 28-day cycle and is expected to increase subject compliance and decrease chemotherapy-induced toxicity. Study Objectives: The primary objective is to demonstrate superiority in progression-free-survival, when erlotinib is added to docetaxel. The secondary objectives are to determine: - Overall survival (defined as the time period from the start of first-line therapy to death) - Time to treatment failure or disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression) - Tumor response rate and duration - Safety profile - Quality of Life improvement - microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening for prognostic purposes

NCT ID: NCT00840086 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

guardian™1
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

NCT ID: NCT00839826 Completed - Thromboembolism Clinical Trials

ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

ODiXaHip
Start date: December 2002
Phase: Phase 2
Study type: Interventional

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

NCT ID: NCT00839163 Completed - Clinical trials for Deep Vein Thrombosis

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

NCT ID: NCT00839007 Completed - Clinical trials for Acute Decompensated Heart Failure

Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.

NCT ID: NCT00838474 Completed - Preterm Infants Clinical Trials

The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants

Start date: October 2007
Phase: N/A
Study type: Interventional

Music has been consistently shown to reduce stress and increase weight gain in premature infants. The mechanism of this presumed improved metabolic efficiency is unknown. We aim to test the hypothesis that music by Mozart reduces energy expenditure in growing healthy preterm infants.

NCT ID: NCT00838188 Completed - Preterm Infants Clinical Trials

Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk

Start date: November 2007
Phase: N/A
Study type: Observational

OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm infants, although there is no evidence that this is actually the case. It is also not known whether the method of feeding affects energy expenditure. We hypothesized that resting energy expenditure (REE) would be higher after breastfeeding than after bottle feeding. PATIENTS AND METHODS. preterm ( >32 weeks GA) stable infants who are nourished entirely by their mothers' breast milk will be studied when fed expressed breast milk either by bottle or at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is evaluated by pre- and post feeding weighing.

NCT ID: NCT00837356 Completed - Clinical trials for Congenital Bleeding Disorder

Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

Start date: March 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

NCT ID: NCT00837291 Withdrawn - Clinical trials for Osteoarthritis of the Knee

A Study of the Efficacy and Safety of CF101 to Patients With Osteoarthritis of the Knee

Start date: November 2018
Phase: Phase 2
Study type: Interventional

This study will test the effectiveness of CF101 in treating the symptoms of osteoarthritis (OA) of the knee. Eligible patients will be given either CF101 or matching placebo tablets and their symptoms will be evaluated over the 12 week treatment period.