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NCT ID: NCT00710138 Completed - Clinical trials for Vitamin B 12 Deficiency

Cobalamin Status in Young Children With Developmental Delay

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

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition. In this study we want to establish the prevalence of cobalamin deficiency in infants with developmental delay and regression and other vague neurological symptoms. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status. Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.

NCT ID: NCT00708942 Terminated - Clinical trials for Cervical Intraepithelial Neoplasia

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

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

The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

NCT ID: NCT00708890 Completed - Clinical trials for Substance Use Disorders

Twelve Step Based Self-help Groups for Substance Related Disorders

TSF_Norway
Start date: September 2008
Phase: N/A
Study type: Interventional

The Twelve Step groups are the most available and widespread self-help groups for patients with alcohol or drug related disorders. In a public health perspective, self-help groups (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon as professional treatment has ended. There is a need to investigate if U.S. findings and procedures concerning referrals from the health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural setting which is unfamiliar with these groups. There is also a particular need in the Norwegian treatment system to develop alternative treatment strategies for patients undergoing detoxification to improve their chances of long-term recovery, due to deficient formal follow-up alternatives. We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned to two different groups: One given standard information about TSGs (brief advice) and one given intensive referral (motivational sessions and contact with TSG volunteers). A follow up assessment is planned at 6 months to determine whether intensive referral results in more TSG attendance, and if this mediates less substance use and better functioning outcomes. This study introduces a new concept in the Norwegian health care system and relies on a systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study focuses strongly on user resources.

NCT ID: NCT00708253 Completed - Clinical trials for Gastrointestinal Diseases

Single- Versus Double-balloon Enteroscopy in Small Bowel Diagnostics

SBE_vs_DBE
Start date: June 2008
Phase: N/A
Study type: Interventional

Background: The small bowel has been a black box for gastrointestinal (GI) endoscopy as, until recently, most of the small bowel was not accessible with conventional endoscopes. Double-balloon enteroscopy (DBE) is an endoscopic procedure for visualizing the entire small bowel. The method was first described by Yamamoto and colleagues in 2001. Both endoscopic diagnosis and treatment can be easily performed using DBE. The first larger series, recently published, demonstrate that DBE is feasible in visualizing large parts of the small bowel. Although DBE has widely been used routinely for examining the small intestine there are a few issues which may limit its use. The preparation and handling of the DBE-endoscope is often interpreted as being complex (such as attaching the balloon to the tip of the endoscope, inflating/deflating the two balloon systems). Recently, a novel balloon 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 endoscopist needs to manipulate only one single balloon; thereby, time and complexity for preparation of the system and for the examination itself may be reduced. However, the new SBE system may be less efficient for deep intubation of the small bowel and may cause adverse effects due to the hooking of the endoscope during straightening of the endoscope. Study Aim: The primary aim of the present study is to compare the new SBE system with the standard DBE system with respect to completeness of visualisation and insertion depth of the small bowel, as well as complications during the procedure.

NCT ID: NCT00707031 Completed - Clinical trials for Diabetes Mellitus, Type 2

GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

GETGOAL-X
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life [PAGI-QOL]).

NCT ID: NCT00706238 Terminated - Melanoma Clinical Trials

MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma

Start date: September 29, 2008
Phase: Phase 2
Study type: Interventional

This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.

NCT ID: NCT00706082 Terminated - Clinical trials for Pulmonary Hypertension

Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)

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

A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension

NCT ID: NCT00705302 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs

Start date: September 2007
Phase: N/A
Study type: Interventional

The aim of this study is to determine the long term effect of a self-help group in a patient education program for patients with chronic obstructive pulmonary disease (COPD).

NCT ID: NCT00704483 Completed - Clinical trials for Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy

Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

SBR759
Start date: July 2008
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

NCT ID: NCT00703755 Completed - Clinical trials for Patients With Metabolic Syndrome

A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.

Start date: March 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study was to study the effect of different combinations of fenofibrate and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to determine the dose combination allowing normalization of MetS patients.