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NCT ID: NCT00794560 Completed - Thromboembolism Clinical Trials

Self-management of Low Molecular Weight Heparin Therapy

Start date: June 2007
Phase: Phase 4
Study type: Interventional

There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment. Hypothesis: Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.

NCT ID: NCT00794287 Withdrawn - Clinical trials for Wasp Venom Allergic Patients

Performance of CAST (Cellular Antigen Stimulation Test) in Patients With Wasp Venom Allergy: Evaluation of Neutralizing IgG Subclasses

Start date: January 2009
Phase: N/A
Study type: Observational

To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST

NCT ID: NCT00794235 Completed - Clinical trials for Melanoma Stage III or IV

Monocentric Pilot Study Investigating the Metabolic Activity of Melanoma in Vivo During Sorafenib and Dacarbazine

Start date: December 2008
Phase: Phase 2
Study type: Interventional

Investigation of the metabolic activity of sorafenib and sorafenib plus dacarbazine on melanoma metastasis in patients with melanoma stage III or IV on the basis of PET/CT, LDH and S-100 evaluation. As we hypothezise a direct influence on the transcriptome by these drugs via antiproliferative or apoptotic signals, biopsies of melanoma skin metastases will be assessed with microarrays and direct changes will be revealed. If positive effects on the transcriptional profiles of metastases are revealed, patients with metastatic melanomas would benefit from these drugs resulting in tumor regressions. Therefore, a total of 12 patients with skin- or superficial lymph node metastases with a diameter of at least 1 cm will be chosen for sorafenib therapy over 56 days per os twice daily with each 400 mg and, additionally, on day 14 and 42, intravenous dacarbazine infusion (volume depending on the body surface area (1000 mg/m2)). Before treatment with sorafenib, before treatment with dacarbazine, and after treatment, S100 and LDH will be measured in serum, PET/CT will be conducted and biopsy will be taken out of one skin metastasis on the same day.

NCT ID: NCT00793286 Completed - Pain Clinical Trials

Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Start date: August 2004
Phase: N/A
Study type: Interventional

Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.

NCT ID: NCT00793273 Completed - Clinical trials for Diabetes Mellitus, Type 2

Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.

Start date: November 2008
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

NCT ID: NCT00792753 Completed - Clinical trials for Coronary Artery Disease

Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"

Start date: October 2008
Phase: N/A
Study type: Interventional

Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200 male and female patients. In a Continued Access Registry of up to 100 patients receiving the DESyne Stent clinical-only endpoints will be evaluated. To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System control through clinical and angiographic endpoints.

NCT ID: NCT00792584 Completed - Sleep Disorders Clinical Trials

Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

SWITCH-EE
Start date: November 2008
Phase: N/A
Study type: Interventional

Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation. The investigators plan a twelve week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2, efavirenz would be continued, and etravirine placebo given in addition. After six weeks, patients in group 1 would switch to the regimen of group 2, and vice versa. The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.

NCT ID: NCT00790920 Completed - Stroke Clinical Trials

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

DIAS-3
Start date: December 2008
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

NCT ID: NCT00790231 Completed - Urodynamics Clinical Trials

Effects of Thoracic Epidural Anesthesia on Lower Urinary Tract Function

Start date: October 2008
Phase: N/A
Study type: Observational

Acute urinary retention is one of the most common complications after surgery and anesthesia. Overfilling the bladder can stretch and damage the detrusor muscle, leading to atony of the bladder. It can occur in patients of both sexes and all age groups and after all types of surgical procedures. Micturition depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Motorneurons of both muscles are located in the sacral spinal cord and coordination between then occurs in the pontine tegmentum of the caudal brain stem. Motorneurons innervating the external urethral sphincter are located in the nucleus of Onuf, extending from the S1 to the S3 segment. The smooth detrusor muscle is inner-vated by parasympathetic fibers, which reside in the sacral intermediolateral cell group and are located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important role in promoting conti-nence and are located in the intermediolateral cell group of the lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated. Because peridural anesthesia can be performed at various levels of the spinal cord and with varying concentrations of local anesthetic, it is possible to block only a portion of the spinal cord (segmental blockade). So it seems logical that peridural analgesia from a Th 2-4 to Th 10-12 will have no influence on the micturition reflex. Studies on the urodynamic effects of various anaesthetic agents are rare. Under the influence of epidural analgesia, patients may not feel the urge to urinate, which may result in urinary retention and bladder over distension. Spinal and epidural opioid administrations influence the function of the lower urinary tract by direct spinal action on the sacral nociceptive neurons and autonomic fibres. It is therefore a common practice for bladder catheterisation in the presence of spinal or epidural anesthesia. The excessive use of a transurethral catheter is undoubtedly associated with significant morbidity such patient discomfort, urinary tract infections, catheter entrapment, bladder calculi formation, urethral trauma and stricture. The risk of infection with a single catheterization is 1-2% and can rise to 3 to 7 % a day. There has yet been no consensus for appropriate catheterisation strategy and urodynamic changes under thoracic epidural anesthesia are still unknown. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters. Our hypothesis is that thoracic epidural analgesia does not influence lower urinary tract function in the male and female. Therefore transurethral catheterization is not mandatory for all patients with thoracic epidural analgesia. Differences in post void residual urine volume and urodynamic examinations before and during thoracic epidural analgesia will be analyzed in 16 men and 16 women undergoing open kidney surgery/lumbotomy who receive thoracic epidural anesthesia perioperatively.

NCT ID: NCT00790036 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

PILLAR2
Start date: July 2009
Phase: Phase 3
Study type: Interventional

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapy