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NCT ID: NCT01702363 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Long-term Safety Study for GSK573719 in Japanese

AC4115361
Start date: August 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.

NCT ID: NCT01700907 Completed - Clinical trials for Postoperative Cognitive Dysfunction

Optimization of Desflurane in Elderly Patients

Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing. Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia. The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

NCT ID: NCT01700335 Completed - Clinical trials for Myelodysplastic Syndrome

Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)

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

The purpose of this study is to investigate tolerability when SyB L-1101 is administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be investigated.

NCT ID: NCT01700140 Completed - Clinical trials for Radiotherapy-induced Nausea and Vomiting (RINV)

Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

NCT ID: NCT01699724 Completed - Healthy Clinical Trials

Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

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

The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects

NCT ID: NCT01699698 Completed - Clinical trials for Pancreatic Adenocarcinoma

Pancreatic Juice Diagnosis From Duodenum

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

Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

NCT ID: NCT01698918 Completed - Clinical trials for Hormone Receptor Positive Breast Cancer

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

BOLERO-4
Start date: March 7, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.

NCT ID: NCT01698801 Completed - Multiple Myeloma Clinical Trials

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

Start date: October 1, 2012
Phase: Phase 2
Study type: Interventional

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

NCT ID: NCT01697605 Completed - Clinical trials for Tumor With Alterations of the FGF-R

A Phase I Study of Oral BGJ398 in Asian Patients

Start date: October 19, 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

NCT ID: NCT01697267 Completed - Clinical trials for Microscopic Polyangiitis

Rituximab Vasculitis Maintenance Study

RITAZAREM
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe. The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab. RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years. The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico. RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health and by Roche/Genentech.