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Showing 10821-10840 of 13,890 trials
NCT00067938
Bipolar study of tolerability, clinical response and patient satisfaction
NCT02082041
The purpose of this study is to monitor the skin blood flow in the lower leg, with different levels and types of applied loads. These loads will not be placed over the patient's wound nor will they be higher than loads the skin normally experiences in daily activities. The results of this research will help investigators understand the development of pressure ulcers, commonly known as bedsores and stasis ulcers.
NCT02222207
Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: * how often the regorafenib eye drops need to be given per day * whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.
NCT00544817
The mechanism of action of sorafenib makes it an interesting drug to investigate in the treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic activity has already been demonstrated and the PDGF receptor target may also be pertinent in glioblastoma. The combination of temozolomide plus sorafenib has been investigated previously in the treatment of patients with advanced melanoma. The combination was generally well tolerated; in previously untreated patients, a standard dose of sorafenib (400mg PO bid) was administered with temozolomide 150mg/m2 PO daily for 5 days, repeated every 28 days (23). In this multicenter phase II study, patients with newly diagnosed glioblastoma will receive standard treatment, including initial debulking surgical resection (if feasible) followed by high-dose radiation therapy with concurrent temozolomide. After completion of radiation therapy, patients will continue treatment with temozolomide (150mg/m2 days 1-5) and sorafenib (400mg PO bid daily), repeated at 28-day intervals for 6 cycles.
NCT00329225
This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have not achieved their blood glucose goal using insulin alone. This study requires a total of seven visits during 28 weeks.
NCT00107757
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.
NCT00706849
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).
NCT01456000
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
NCT00967304
The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.
NCT01591681
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. This study has several phases and will take about 3 months for a patient to complete. Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure that they are able and willing to use this system and to determine if they meet the investigators study criteria to proceed with the next phase of the study. Patients will be provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to complete the CGM run-in phase will have an extra office visit for training. If eligible to continue in the study, patients will need to use the study system for 5 nights at home so that the investigators can make sure they are able to use it correctly. After that, patients will be asked to use the study system each night for an additional 6 to 8 weeks. If the system is active and predicts that a patient's blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include about 45 individuals at 3 clinical centers in the United States and Canada.
NCT01823341
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur. We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk. This study has several phases and will take about 3 months for a patient to complete. * First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study. * If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed. * After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed. The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.
NCT01838499
The purpose of this study is to gain initial evidence for the safety, tolerability and efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis suppurativa
NCT00496262
This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness \[MCF\]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.
NCT00770146
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).
NCT00109330
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
NCT01286753
This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.
NCT01358357
This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.
NCT00274677
This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.
NCT01342484
The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.
NCT01742052
The primary objectives of the study are: * To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters * To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.
