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NCT ID: NCT01203631 Completed - Inflammation Clinical Trials

Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

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

This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.

NCT ID: NCT01203176 Recruiting - Clinical trials for Malignant and Pre-malignant Changes in the Polyp

Incidence of Malignant and Premalignant Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women

Start date: September 2010
Phase: N/A
Study type: Interventional

The prevalence of endometrial polyp is 24% in the general population but is much higher in postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 2 to 10% in menopausal women. Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care, same goes for asymptomatic women with risk factors for endometrial malignancy, however treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is disputable. In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, the investigators are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp

NCT ID: NCT01203111 Completed - Clinical trials for Diabetes Mellitus, Type 2

Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

CHANGING
Start date: December 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10). Secondary Objectives: 1. Percentage of patients with HbA1c < 7% at week 24. 2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24. 3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24. 4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24. 5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24. 6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

NCT ID: NCT01202786 Completed - Clinical trials for Neoplasms, Unknown Primary

Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)

Start date: May 2010
Phase: N/A
Study type: Observational

The aim of the study is in cancer of unknown primary (CUP) patients, to compare the cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary tumor site.

NCT ID: NCT01202565 Completed - Clinical trials for Moderate to Severe Plaque Psoriasis

Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Start date: September 2010
Phase: N/A
Study type: Observational

There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice. The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.

NCT ID: NCT01201993 Suspended - Recurrence Clinical Trials

Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients

Start date: August 2010
Phase: N/A
Study type: Observational

The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.

NCT ID: NCT01201499 Not yet recruiting - Pain Clinical Trials

Comparing the Outcome of Two Intraoperative Analgesia Techniques After Hepato-pancreato-biliary Surgery

Start date: November 2010
Phase: N/A
Study type: Interventional

Inadequate pain control after abdominal procedures may lead to adverse postoperative outcome. Epidural analgesia is currently an accepted technique in abdominal surgery, but its use has been limited in liver resections by postoperative coagulation disturbances and the possible increased risk of bleeding complications, including spinal hematoma. A range of alternative analgesic techniques can be used for major liver or pancreatic resections, including intrathecal morphine (single shot) administered immediately before surgery, and continuous administration of intravenous (IV) short-acting opioids, such as remifentanil, plus a single bolus of IV morphine. Postoperatively analgesia may be obtained by patient-controlled morphine analgesia (IV PCA). Both protocols have been demonstrated to provide satisfactory postoperative pain relief, and each has its unique advantages. However, to this end there is no data in the literature to show benefit from one regimen over the other. We therefore wish to determine whether there is a difference in analgesic efficacy between the two techniques, as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost importance. Our hypothesis is that continuous intraoperative IV analgesia with remifentanil followed by IV PCA morphine is not inferior to intrathecal morphine with respect to analgesia and ambulation outcome, and may provide an alternative, non-invasive intraoperative analgesic technique.

NCT ID: NCT01201356 Completed - Clinical trials for Relapsing Forms of Multiple Sclerosis

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Start date: September 13, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

NCT ID: NCT01201226 Not yet recruiting - Low Ovarian Reserve Clinical Trials

Can Dormant Perimenopausal Ovarian Follicles Become FSH Responsive?

Start date: November 2010
Phase: N/A
Study type: Interventional

The purpose of this study to obtain ovarian cortical fragments from perimenopausal patients, who undergo pelvic organ surgery and test whether treatment with PTEN inhibitor and PI3K activating peptide would induce these fragments to produce FSH responsive follicles in the nude mouse model.

NCT ID: NCT01201174 Not yet recruiting - Hemolysis Clinical Trials

Hemolysis in Patients With Hereditary Spherocytosis (HS)

Start date: September 2010
Phase: N/A
Study type: Interventional

In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis