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NCT ID: NCT00531804 Completed - Alzheimer's Disease Clinical Trials

A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

Start date: December 2006
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00531713 Completed - Depression Clinical Trials

Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism

T4-T3
Start date: April 2003
Phase: Phase 4
Study type: Interventional

To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

NCT ID: NCT00531037 Completed - Clinical trials for Patients Implanted With a Pacemaker

Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

NATURE
Start date: June 2007
Phase: N/A
Study type: Observational

Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

NCT ID: NCT00530855 Completed - Epilepsy Clinical Trials

Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

Start date: February 2008
Phase: Phase 3
Study type: Interventional

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

NCT ID: NCT00530439 Completed - Clinical trials for Gestational Weight Gain

Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women

LiP
Start date: October 2007
Phase: N/A
Study type: Interventional

Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese. Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted. Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy. 360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups. Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.

NCT ID: NCT00530075 Completed - Clinical trials for Wegener's Granulomatosis

Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

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

Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. The efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. A prospective, international, nulti-centre, single limb, open label study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate. Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0 for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle azathioprine was commenced and follow-up continued for a further six months.

NCT ID: NCT00529425 Completed - Clinical trials for Femoral Neck Fracture

Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

Start date: January 2008
Phase: Phase 4
Study type: Interventional

Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

NCT ID: NCT00529048 Completed - Incretin Effect Clinical Trials

Quantification of the Incretin Effect in Healthy Subjects and Patients With Type 2 Diabetes

Start date: October 2007
Phase: N/A
Study type: Observational

Patients with T2DM lac a sufficient incretin response after oral glucose intake. It has only been tested using 50g of glucose. We don't know if patients with T2DM are capable of regulating the incretin effect like healthy people in responds to different amounts of glucose intake. The aim of the present study is to quantify the incretin effect in healthy subjects and in patients with T2DM during increasing amounts of oral glucose challenges. The proposed studies will answer important questions on the mechanisms underlying T2DM and be of importance in relation to future preventive- and treatment strategies.

NCT ID: NCT00526370 Completed - Clinical trials for Uterine Cervical Neoplasms

Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Start date: August 2007
Phase: Phase 0
Study type: Observational

The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses. Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.

NCT ID: NCT00526136 Completed - Atrial Fibrillation Clinical Trials

Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

Start date: March 2007
Phase: Phase 2
Study type: Interventional

To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).