Terminating clinical trials without sufficient subjects.

Medical research involving human subjects can be risky and burdensome. Therefore, such research must be reviewed and approved by a Research Ethics Committee (REC). To guarantee the safety of the subjects, it is very important that these studies be conducted in accordance with the approved protocol.

The long-term outcome of transcutaneous electrical nerve stimulation in the treatment for patients with chronic pain: a randomized, placebo-controlled trial.

Background: Transcutaneous electrical nerve stimulation (TENS) is an easy to use analgesic intervention. However, long-term randomized placebo-controlled studies with treatment periods of more than 3 months have not been executed to date. The aim of our study is to explore the long-term (1 year) time course of the treatment effects of TENS compared to placebo (sham TENS).

Validation of clinical and image skin scoring systems for a single chronic discoid lupus erythematosus lesion.

Objective: The purpose of this study was to achieve a validated clinical and image scoring system for a single chronic discoid lupus erythematosus (CDLE) lesion.

Methods: Fifteen patients with a CDLE lesion were scored twice by four observers and clinical photographs were taken. These pictures were assessed by the same four observers at two time points.

Predicting outcome of TENS in chronic pain: a prospective, randomized, placebo controlled trial.

Unlabelled: Transcutaneous electrical nerve stimulation (TENS) is an easy to use non-invasive analgesic intervention applied for diverse pain states. However, effects in man are still inconclusive, especially for chronic pain. Therefore, to explore the factors predicting result of TENS treatment in chronic pain we conducted a prospective, randomized, placebo-controlled trial (n=163), comparing high frequency TENS (n=81) with sham TENS (n=82).

Outcome of transcutaneous electrical nerve stimulation in chronic pain: short-term results of a double-blind, randomised, placebo-controlled trial.

The aim of this study was to test the efficacy of shortterm transcutaneous electrical nerve stimulation (TENS) treatment in chronic pain with respect to pain intensity and patients' satisfaction with treatment results. We therefore performed a randomised controlled trial comparing TENS and sham TENS. Patients, researchers and therapists were blinded for treatment allocation.

Cost-effectiveness of adding granulocyte colony-stimulating factor to primary prophylaxis with antibiotics in small-cell lung cancer.

Purpose: Recently, a Dutch, randomized, phase III trial demonstrated that, in small-cell lung cancer patients at risk of chemotherapy-induced febrile neutropenia (FN), the addition of granulocyte colony-stimulating factor (GCSF) to prophylactic antibiotics significantly reduced the incidence of FN in cycle 1 (24% v 10%; P = .01). We hypothesized that selecting patients at risk of FN might increase the cost-effectiveness of GCSF prophylaxis.

Sulprostone reduces the need for the manual removal of the placenta in patients with retained placenta: a randomized controlled trial.

Objective: The purpose of this study was to determine the extent that the administration of sulprostone reduces the need for manual removal of the placenta in patients with retained placenta.

Study Design: A double-blinded sequential randomized controlled trial of sulprostone versus placebo was conducted among 103 patients with retained placenta.

Results: In the first phase of this sequential study, sulprostone was compared with placebo.

Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: a Dutch Randomized Phase III Study.

Purpose: Febrile neutropenia (FN) is a major complication of chemotherapy. Antibiotics as well as granulocyte colony-stimulating factor (G-CSF) are effective in preventing FN. This multicenter randomized phase III trial determines whether the addition of G-CSF to antibiotic prophylaxis can further reduce the incidence of FN in patients with small-cell lung cancer (SCLC) at the risk of FN.

The effect of treatment on quality of life in psoriasis patients.

Psoriasis is a chronic skin disease with substantial impact on patients' social and relational ways of living and subsequently on their quality of life. The aim of this study was to evaluate the health-related quality of life (HRQoL) of patients with moderate to severe psoriasis treated with short contact dithranol treatment, UVB phototherapy or inpatient dithranol treatment. HRQoL was evaluated in an open randomized multicentre study by appliance of the Dutch short form of the Sickness Impact Profile and the Psoriasis Disability Index; 250 patients were included.

Diaphragm dysfunction in chronic obstructive pulmonary disease.

Rationale: Hypercapnic respiratory failure because of inspiratory muscle weakness is the most important cause of death in chronic obstructive pulmonary disease (COPD). However, the pathophysiology of failure of the diaphragm to generate force in COPD is in part unclear.

Objectives: The present study investigated contractile function and myosin heavy chain content of diaphragm muscle single fibers from patients with COPD.

Minimization of sample size when comparing two small probabilities in a non-inferiority safety trial.

In clinical trials success rates of two treatments to be compared often range from 10 to 90 per cent. When the comparison probabilities are (much) smaller than 10 per cent, standard methods for sample size and power calculations may provide invalid results. This situation may occur when there is interest in safety rather than in efficacy.

Cost-effectiveness of infant orthopedic treatment regarding speech in patients with complete unilateral cleft lip and palate: a randomized three-center trial in the Netherlands (Dutchcleft).

Objective: To investigate the cost-effectiveness of infant orthopedic treatment (IO), compared with no such treatment in children with complete unilateral cleft lip and palate (UCLP) focusing on the effects on speech development at age 2.5 years.

Design: In a three-center prospective, randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed longitudinally: one group was treated with IO based on a modified Zurich approach in the first year of life (IO group) and the other group did not receive this treatment (non-IO group).

Administration of indinavir and low-dose ritonavir (800/100 mg twice daily) with food reduces nephrotoxic peak plasma levels of indinavir.

Background: The objective of this study was to compare indinavir peak plasma (Cmax) values after administration of indinavir/ritonavir 800/100 mg on an empty stomach or with food. High indinavir Cmax values have been associated with indinavir-related nephrotoxicity.

Methods: This was an open-label, randomized, two-treatment, two-period, cross-over pharmacokinetic study performed at steady state.

Preconception counseling improves folate status of women planning pregnancy.

Objective: To assess whether counseling women planning pregnancy to start or continue folic acid supplementation improves folate status.

Methods: Women and their partners reported folic acid supplement intake in a preconceptional health questionnaire, and the women were categorized as reported "users" or "nonusers" of supplements before counseling. The use of periconceptional folic acid was addressed at a subsequent preconceptional consultation.

The efficacy of radiofrequency lesioning of the cervical spinal dorsal root ganglion in a double blinded randomized study: no difference between 40 degrees C and 67 degrees C treatments.

The efficacy of radiofrequency lesion treatment of the cervical dorsal root ganglion (RF-DRG) in cervicobrachialgia was investigated in 61 patients by a randomized prospective double blinded study. Before lesion treatment the putative pain provoking spinal root was identified by diagnostic blocks with a local anesthetic agent. One group of patients (n = 32, group I) was treated with a radiofrequency lesion of 67 degrees C and in a control group (n = 29, group II) a temperature of 40 degrees C was applied.