Articles Related to randomized
Efficacy of Standardized Ginger Extract in Subjects with Occasional Constipation: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study
Occasional constipation is associated with infrequent bowel movement and difficulty in passing stools without any obvious symptoms. Ginger has been used traditionally to manage various gastric conditions like constipation, dyspepsia, belching, bloating, epigastric discomfort, indigestion, nausea, and vomiting. The current study evaluated the effects
of a standardized Ginger extract (GE) on objective and subjective markers of occasional constipation in a randomized, double-blind, parallel, placebo-controlled design
Supercapsular Percutaneously-Assisted Approach Versus Conventional Posterolateral Approach for Primary Total Hip Arthroplasty: A Prospective Randomized Controlled Study
Background: Super capsular percutaneously-assisted total hip (Super PATH) approach has been regarded as one of minimally invasive and muscle sparing technique, which accesses the hip maintaining integrity of the external rotators and capsule. The purpose of this study was to compare the Super PATH approach with the conventional posterolateral approach in terms of early clinical outcomes and radiological results.
Pharmacodynamic Equivalence of Ovine Enoxaparin to Porcine Enoxaparin (Lovenox®) In Healthy Volunteers: A Randomized, Open-Label, 2-Way Cross-Over, Single Dose Study
Aim: to demonstrate the PK/PD equivalence of an ovine enoxaparin to the reference product, the originator porcine enoxaparin, Lovenox® from Sanofi, and to assess its safety and tolerability in healthy volunteers with s.c. administration.
Methods: a randomized, open-label, 2-way cross-over, single-dose study with 7 days wash-out period was conducted in healthy volunteers of both sexes. A single s.c. injection of 6,000 IU ovine enoxaparin from Metiska Farma (the test drug, T) or Lovenox® from Sanofi (the reference drug, R) was given randomly to each subject in fasting condition. The PD endpoints measured were anti-FXa and anti-FIIa activities in plasma, whereas the PD parameters determined for these endpoints were AUEC0-t (area under the effect curve from time 0 to the last measured activity (t)) and Amax (maximum activity). Bioequivalence (BE) is based on anti-FXa activity, the 90% CIs for GMR T/R (geometric means ratio of Test/ Reference) of AUEC0-t and Amax must fall within the BE limits of 80.00 – 125.00%. The anti-FIIa data are in vivo supportive evidence only.
Results: a total of 23 healthy volunteers completed this study. The 90% CIs for GMR T/R of AUEC0-t and Amax for anti-FXa were 107.55 – 116.33% and 110.17 – 117.68%, respectively, while those for anti-FIIa were 100.93 – 122.56% and 105.19 – 124.44%, respectively. All parameters fell within the BE criteria of 80.00 – 125.00%. One AE (adverse event) occurred in one volunteer after s.c. injection of ovine enoxaparin, i.e. bruising which disappeared after a few days.
Conclusions: the ovine enoxaparin from Metiska Farma was bioequivalent to the reference porcine enoxaparin (Lovenox®) from Sanofi. Both enoxaparin products were shown to have high safety and tolerability after a single dose in healthy volunteers. This is the first study showing BE of a nonporcine enoxaparin to the reference porcine enoxaparin in Indonesia, a Moslem country
A Java Software for Randomized Phase II Clinical Cancer Trial Designs
Traditionally, a typical phase II trial has been conducted using a single-arm design recruiting patients only to the
experimental therapy to be compared with a historical control. Due to a small sample size and heterogeneity of patient
population, the patient characteristics of the patients in a new phase II trial is often different from that of the selected
historical control, so that the single-arm phase II trial may lead to biased conclusions. A randomized phase II trial
can resolve such problems by randomizing patients between an experimental arm and a control arm. We propose a
software package for designing and analyzing randomized phase II trials.
We develop a user-friendly Java software that will help us find optimal two-stage phase II trial designs. Although the programs accommodate trial designs based on various statistical methods and different types of early stopping rules, the
main part of our paper is focused on randomized phase II trials based on Fisher’s exact test with futility and superiority
early stopping values. If users enter input parameter values, the software generates a graphical output displaying all
efficient two-stage designs. Minimax, optimal, and admissible designs are highlighted as good designs, but users can
select any of the displayed designs. When the circle representing a design is clicked, all the specifics of the selected design
are displayed. Fisher’s test is an exact method whose critical values depend on the total number of responders from two
arms. So, the computations required to search for optimal randomized multi-stage phase II trial designs based on Fisher’s
exact test is very heavy. By using efficient algorithms, our software provides output at almost real time speed
Application of the Posterior Approach Technique in Laparoscopic Radical Hysterectomy for Cervical Cancer
The aim of this study was to compare and determine the feasibility, surgical outcomes, intraoperative and postoperative
complications of the use of the posterior approach technique in the laparoscopic radical hysterectomy (LRH) to the conventional
laparoscopic radical hysterectomy in patients with cervical cancer.
Functional Outcomes of Stapes Surgery with Titanium and Teflon Prosthesis: Randomized Controlled Trial
Prosthesis material and design is thought to have a role in effective sound transmission, rate of complications and success of stapes
surgery. Titanium has been shown to be a promising material in this regard. We compared the intra-operative events, complication rate
and the hearing outcomes results of stapes surgery using titanium versus fluoroplastic piston prosthesis.
Fuel Metabolism Following 3 Days on a Carbohydrate-Free Diet vs. 3 Days of Fasting in Men with Type 2 Diabetes: A Randomized Controlled Crossover Trial
A 72-h fast results in a rapid decrease in circulating glucose to a lower level without a change in non-water body mass. Several metabolic adjustments are necessary. A nutrient-sufficient, carbohydrate (CHO)-free diet also has been reported to result in a decrease in glucose, and similar metabolic perturbations. However, direct comparisons are not available in subjects without, or with, type 2 diabetes (T2DM).
A Randomized Double-Blind Placebo Controlled Clinical Trial Evaluating the Effects of an Investigational Study Product on Exercise Induced Muscle Soreness, Markers of Inflammation, Muscle Damage and Exercise Performance in Healthy Males
Gherkin, a pure botanical extract from cucumber is a phytonutrient rich vegetable which may have been shown to have anti-inflammatory and pain relieving properties. The purpose of this randomized double-blind placebo study was to determine the effects of Gherkin (Cuvitus™, Actido®)on exercise performance, markers of inflammation and acute muscle soreness in healthy males.
Labetalol in Comparison to Methyl Dopa in Treatment of Gestational Hypertension, A Randomized Trial
To evaluate the value and safety of labetalol in comparison to Alfa methyldopa in treatment of pregnant women with pregnancy-induced hypertension (PIH). 264 patients with PIH were randomly distributed to take either methyldopa (group 1) labetalol (group 2). or Intake of medications with respect to Age, gravidity, Blood Pressure measurement, albumin in urine measurement Levels, Side Effects, dose of the drug, increasing duration of pregnancy, mode of delivery, Perinatal safety and APGAR scores were studied. The statistical level of significance was taken at P<0.05.
Efficacy of Vitamin C Vaginal Suppository in Treatment of Bacterial Vaginosis a Randomized Controlled Trial
The aim of the current study was to compare the efficacy and side effects of vaginal vitamin C suppository and vaginal metronidazole in treatment of bacterial vaginosis. Double-blind randomized controlled trial. The study included women who presented to the outpatient gynecological clinic with a diagnosis of bacterial vaginosis by amsels criteria. The included eligible women were randomly allocated in one of two groups: group I, including women who received vitamin C vaginal suppository once daily at bed time for 6 days; and group II, including women who received metronidazole 500 mg vaginal suppository once daily at bed time for 6 days. All included women were reviewed in 8-14 days after completion of treatment for reevaluation.
Bioequivalence Study of Two Oral-Capsule Formulations of Omeprazole 20 mg in Combination with Sodium Bicarbonate in Healthy Mexican Adult Volunteers
In Mexico, the immediate-release formulation of omeprazole 20 mg in combination with 1100 mg of sodium bicarbonate (oral capsules) is indicated for patients over 18 years for the treatment of gastritis, reflux, heartburn and the sensation of emptiness caused by the excessive acid production.
Treatment of Dentin Hypersensitivity: A Systematic Review of Randomized Clinical Trials
Dentin hypersensitivity (DH) is generally described as “a brief, sharp, and acute pain emanating from exposed dentin in response to thermal, tactile, osmotic, or chemical stimuli, as well as exposure to air that cannot be attributed to any dental anomaly or pathology”.
ESBL-Producing E. Coli in a Patient on Automated Peritoneal Dialysis
Peritoneal Dialysis (PD) is one of the 3 well-established modalities of renal replacement therapy used in patients with renal failure. Despite its significant role as a successful method of renal replacement therapy, PD is highly associated with peritonitis and catheter-related infections.
Randomized Study of the Effects of Statin on Inflammatory and Prothrombotic States in Obese Adolescents
Obesity is a major public health concern in many countries. In Europe 4.1% of the girls and 5.4% of the boys aged 10-12 years are obese according to the International Obesity Task Force criteria.
C-MAC Video Laryngoscopy Versus Flexible Fiberoptic Laryngoscopy in Patients with Anticipated Difficult Airway: A Randomized Controlled Trial
Tracheal intubation is one of the most common medical procedures performed in hospitals. On one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful.
Editorial Board Members Related to randomized
Paulo Nunes Costa Filho
School of Physical Education and Sports, Rio de Janeiro Federal University, Av. Carlos Chagas Filho, 540 - Cidade Universitária, Rio de Janeiro, RJ, 21940-901, Brazil.
