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NCT ID: NCT00961415 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer

Start date: August 2009
Phase: Phase 3
Study type: Interventional

This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 individuals.

NCT ID: NCT00960661 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

NCT ID: NCT00960128 Completed - Clinical trials for Chronic Kidney Disease

Observational Prospective Study on Patients Treated With Norditropin®

Start date: April 1, 2006
Phase: N/A
Study type: Observational

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

NCT ID: NCT00959790 Completed - Obesity Clinical Trials

Vegetable Consumption in Relation to Health

8374
Start date: January 2009
Phase: N/A
Study type: Interventional

Rationale: Consumption of vegetables is generally considered to be associated with several positive effects on health. Vegetables are a heterogeneous group of our diet which is rich in bio-actives. The vegetables contain a range of vitamins, minerals, dietary fibres and phytochemicals like potassium, flavonoids, carotenoids, and vitamin C. The recommended intake of vegetables by the Dutch Health Council is 200 grams daily (Health Council, 2006). Health in this project is defined as the possibility of a subject to change and adapt easily in response to a certain challenge. Healthy subjects show resilience in different physiological processes related to oxidative stress, metabolic stress, neurological stress and inflammatory stress. The reaction/response to a challenge might be changed when subjects have consumed more or less vegetables and have an improved health status. The response might also differentiate between subjects differing in BMI (healthy weight versus overweight/obese). Supplementation of vegetables will be provided in two conditions: a low and a high daily intake (50 versus 200 grams daily). An intervention known to have positive effects on health is weight loss. This will be studied in relation to health (the reaction to the challenge test) as well. A beneficial effect is present when 5% improvement of health markers is shown with vegetable supplementation, similar as is known from weight loss studies. Objective: The primary objective of the present study is to set-up a methodology to investigate health based on the resilience to challenge. A secondary objective is the effectiveness of the challenge concept with a food intervention. The vegetable supplementation study is a first example to test the challenge concept. Therefore, vegetable consumption according to the recommendations of the Dutch Health Council of 200 grams of vegetables daily will be studied with an exercise challenge test, to investigate the beneficial 'health' effects.

NCT ID: NCT00958230 Completed - Clinical trials for Peripheral Arterial Vascular Occlusion

dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission

Start date: August 2009
Phase: N/A
Study type: Interventional

The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair the incision after removal of an atherosclerotic plaque that was stopping usual blood flow to the limbs). Data is being collected to show the procedure is safe and allows for normal blood flow to be resumed. Data will be used to facilitate CE Mark submission.

NCT ID: NCT00956878 Completed - Pain Clinical Trials

Cancer Pain Single Nucleotide Polymorphisms (SNPs)

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

Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human DNA. Using blood samples from clinically well-defined cancer pain patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in genes that are known to be involved in responsiveness to opioids and sensitivity to pain.

NCT ID: NCT00956241 Completed - Rectal Cancer Clinical Trials

J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer

Start date: April 2002
Phase: N/A
Study type: Interventional

The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.

NCT ID: NCT00956033 Completed - Multiple Myeloma Clinical Trials

Skin Biopsies in Chemotherapy-Induced Neuropathy

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

Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.

NCT ID: NCT00955279 Completed - Sarcoidosis Clinical Trials

A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis

Start date: November 2009
Phase: Phase 2
Study type: Interventional

This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally.

NCT ID: NCT00954447 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.