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NCT ID: NCT01525810 Completed - Hepatitis C Clinical Trials

Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

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

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

NCT ID: NCT01525615 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD

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

The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

NCT ID: NCT01525550 Completed - Clinical trials for Well-differentiated Pancreatic Neuroendocrine Tumor

A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

Start date: June 6, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

NCT ID: NCT01524926 Completed - Clinical trials for Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma

CREATE: Cross-tumoral Phase 2 With Crizotinib

CREATE
Start date: September 2012
Phase: Phase 2
Study type: Interventional

The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.

NCT ID: NCT01524861 Completed - Clinical trials for Apical Ballooning Syndrome

Sympathetic Heart Innervation in Patients With Tako-Tsubo Cardiomyopathy

Start date: December 2011
Phase: Phase 4
Study type: Interventional

Stress (tako-tsubo) cardiomyopathy (SC) is a rapidly reversible form of acute heart failure reported to be triggered by stressful events and associated with a distinctive left ventricular (LV) contraction pattern. SC mimics acute coronary syndrome and is accompanied by reversible left ventricular apical ballooning in the absence of angiographically significant coronary artery stenosis. sympathetic activity dysfunction appears to play a very important role in the pathophysiology of takotsubo cardiomyopathy. In most cases, myocardial scintillography with 123Imetaiodobenzylguanidine (MIBG) showed altered captation of the radiotracer in several heart segments. In particular, the apical myocardium has poor sympathetic innervations and an uptake reduction in MIBG tracer. A hypothesis for this finding could be that the intense discharge of adrenalin, acting on heart segment with different and abnormal innervation, may produce a transient heart failure characterized by a particular shape of the left ventricle. While studies have shown that heterogeneous MIBG distribution, decreased MIBG uptake and increased norepinephrine content were completely prevented by α-lipoic acid or by L-acetyl carnitine administrations in diabetic cardiomyopathy, no studies have examined the effects of these therapies on tako-tsubo cardiomyopathy. On this basis, the investigators study will evaluate whether the dysfunction of adrenergic cardiac innervation, evaluated by MIBG, persist after previous experience of transient stress-induced cardiac dysfunction. Moreover, the investigators will assess whether the medications that restore sympatho-vagal alterations in diabetic cardiomyopathy, such as α-lipoic acid and L-acetyl carnitine, will improve the adrenergic cardiac innervation, in patients with SC.

NCT ID: NCT01524783 Completed - Clinical trials for Neuroendocrine Tumors

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

RADIANT-4
Start date: March 30, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.

NCT ID: NCT01524055 Completed - Pain Clinical Trials

CO2 Insufflation During Single-Balloon-Enteroscopy

Start date: December 2011
Phase: Phase 3
Study type: Interventional

Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel. In 2008, a novel balloon-assisted enteroscope system has been developed using only a single balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of the small bowel. The investigators could demonstrate the both endoscopic procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air, however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy, significant amounts of air are usually retained in the bowel segment inspected. This air has to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and discomfort during and after the examination due to the retention of air have been shown to be very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these studies, CO2 insufflation had almost completely reduced procedure-related pain and discomfort. In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no study has been performed investigating the use of CO2 in SBE. The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.

NCT ID: NCT01523860 Completed - Follicular Lymphoma Clinical Trials

Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma

FLE09
Start date: June 2009
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.

NCT ID: NCT01523847 Completed - Hodgkin Lymphoma Clinical Trials

A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

HD0803
Start date: November 2010
Phase: Phase 2
Study type: Interventional

The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen.

NCT ID: NCT01523834 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Oral Panobinostat Adult Patients DLBCL Relapsed/Refractory Stem Cell Transfusion (ASCT) or Not Eligible for ASCT

FIL_PanAL10
Start date: February 2011
Phase: Phase 2
Study type: Interventional

Treatment of adult patients with Diffuse Large B-cell Lymphoma (DLBCL), relapsed or refractory to previous CHOP-R (or CHOP-R like regimen) front line therapy, relapsed or refractory to second or subsequent salvage therapies which included high dose therapy with autologous stem cell support (ASCT). Treatment of adult patients with DLBCL relapsed or refractory to front line therapy with CHOP-R (or CHOP-R like regimen) or subsequent treatments, who are not consider eligible for ASCT consolidation because of age, co-morbidities, impossibility to perform ASCT. The trial is conducted according to the optimal two-stage design of Simon with alpha 0.05 and beta 0.10, considering the following two hypotheses: first a response rate (RR) less than 10% is of no further interest; and second, an RR 30% is clinically meaningful. In the initial stage, 18 patients have to enter onto the study. If less than 3 responses (</=2 in 18) will be observed, the trial would be terminated. Otherwise, accrual will continue to a total of a maximum of 35 patients. At the end of the trial, if 6 or fewer responses will occur among the 35 patients (</= 6 in 35), it will be concluded that the regimen is not worthy of further investigations for that group of patients. The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason).