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NCT ID: NCT01849874 Terminated - Clinical trials for Low-grade Serous Ovarian Cancer

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

Start date: June 27, 2013
Phase: Phase 3
Study type: Interventional

The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

NCT ID: NCT01848561 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: April 29, 2013
Phase:
Study type: Observational

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

NCT ID: NCT01847859 Completed - Clinical trials for Cardiothoracic Surgery

Pocket-size Ultrasound by Nurses in Cardiothoracic Post-operative Patients

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

The investigators aim to study the feasibility and reliability of pocket-size diagnostic ultrasound examinations performed by nurses of postoperative patients who have underwent cardiothoracic surgery in a cardiac unit.

NCT ID: NCT01847690 Unknown status - Addison Disease Clinical Trials

Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The conventional glucocorticoid replacement therapy in primary adrenal insufficiency- Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Many patients take stress-doses that are extra doses of hydrocortisone or cortisone acetate before or during stressful physical or psychological events. However, the effect of such dosing has not been tested in scientific studies. In this double blind cross-over designed pilot trial we aim to test the effect of an extra dose of cortisol on physical activity and hormone levels.

NCT ID: NCT01847274 Completed - Ovarian Neoplasms Clinical Trials

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Start date: June 21, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

NCT ID: NCT01846026 Withdrawn - Ulcerative Colitis Clinical Trials

Ulcerative Colitis and Vitamin D Supplementation

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis. In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis. Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis: - reduces relapse frequency and increase the duration of the Infliximab induced remission - mediates and changes the cytokines composition in the colic mucosa - decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers - augments bone mass

NCT ID: NCT01845233 Completed - Hypoventilation Clinical Trials

Monitoring of Non-invasive Ventilation

Start date: May 2013
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.

NCT ID: NCT01844505 Active, not recruiting - Clinical trials for Unresectable or Metastatic Melanoma

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Start date: June 11, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

NCT ID: NCT01843335 Terminated - Clinical trials for Abdominal Aortic Aneurysm

Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair

Start date: September 2014
Phase: N/A
Study type: Observational

X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.

NCT ID: NCT01843322 Completed - Aortic Aneurysm Clinical Trials

Endoleak Repair Guided by Navigation Technology

Start date: April 2011
Phase: N/A
Study type: Interventional

The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation technology instead of computed tomography (CT) guidance of the needle puncture? Parameters logged during the procedure: - was the needle placement successful? - number of needle punctures? - time used on guidance procedure - X-ray exposure dose