Clinical Trials Logo

Filter by:
NCT ID: NCT01740011 Completed - Hernia Clinical Trials

Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal

AirSeal
Start date: January 2013
Phase: N/A
Study type: Interventional

The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems. It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.

NCT ID: NCT01739855 Completed - Clinical trials for Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation

Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)

BABS
Start date: November 2012
Phase: Phase 2
Study type: Interventional

Bariatric surgery leads to rapid weight loss in female and male patients. Less data are available about its impact on bone metabolism. The aim of this study is the investigation of changes in bone mineral density,bone histomorphometric changes, serum bone turnover markers and changes in body fat and muscle composition in patients after laparoscopic gastric bypass surgery.

NCT ID: NCT01737294 Completed - Clinical trials for Peripheral Neuropathic Pain

Observation of the Use of QUTENZAâ„¢ in Standard Clinical Practice

ASCEND
Start date: February 2012
Phase: N/A
Study type: Observational

This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice. The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic pain; and 'other' neuropathies.

NCT ID: NCT01736475 Completed - Hemophilia A Clinical Trials

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

Start date: January 31, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.

NCT ID: NCT01735955 Completed - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

Start date: March 29, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and were benefiting from the treatment as judged by the investigator

NCT ID: NCT01734928 Completed - Multiple Myeloma Clinical Trials

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

OPTIMISMM
Start date: January 7, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

NCT ID: NCT01734343 Completed - Cataract Clinical Trials

Posterior Capsule Opacification Development With Two Different Intraocular Lenses

MIPHY
Start date: January 2009
Phase: N/A
Study type: Interventional

Age-related cataract is the main cause of impaired vision in the elderly population worldwide. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications. The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag. Modifications in IOL design and material lead to a decrease in the incidence of PCO. During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design. The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 3 years.

NCT ID: NCT01734252 Completed - Clinical trials for Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance

Argatroban in Critically Ill Patients With Heparin Resistance

Start date: July 29, 2012
Phase: Phase 2
Study type: Interventional

Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H. All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec (Pathromtin® SL) within 6 to 8 hours. Randomisation Group A: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. Randomisation Group H - Standard therapy: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. Therapy failure Group H: Primary target failure at Visit 3 (6-8 hours): If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (T1 / day 30). Maintenance failure after Visit 3: Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to be changed to Argatroban. The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (day 30) counting from the Baseline of Group A. Therapy failure Group A: If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further study period, the patient automatically drops out of the study. The same is effective for patients who switched to the Group A after a therapy failure in Group H. General: Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30 days after inclusion in the study, a final investigation is planned (T9).

NCT ID: NCT01732861 Completed - Clinical trials for Leukemia Lymphocytic Chronic B-Cell

Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

Start date: December 28, 2012
Phase: Phase 1
Study type: Interventional

This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).

NCT ID: NCT01732796 Completed - Clinical trials for Hepatitis C, Chronic

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

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

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.