Clinical Trial

Caffeic acid phenethyl ester (CAPE) is the major pharmacologically-active component of some propolis types, rich in polyphenols, such as poplar propolis types. CAPE has the potential to be applied as a pharmaceutical as it possesses most of the pharmacological activities of propolis, such as anti-proliferative, antioxidant, immunomodulatory, antidiabetic, anti-inflammatory and antimicrobial. Its advantage is that it lacks some of the downsides of total propolis extracts, such as inability for unified standardization, which is cornerstone for implementing its therapeutic potential as a drug. The current paper provides an overview on the pharmacodynamic principles of CAPE. We present literature search outcomes form ClinicalTrials.gov database and from scientific publications, available on Scopus and Crossref databases. We take a round view of CAPE’s potential therapeutic implications in light of approved drugs with related modes of action.

We carried out a blinded prospective randomised controlled trial comparing 2-octylcyanoacrylate (OCA), subcuticular suture (monocryl) and skin staples for skin closure following total hip and total knee arthroplasty. We included 102 hip replacements and 85 of the knee. OCA was associated with less wound discharge in the first 24 hours for both the hip and the knee. However, with total knee replacement there was a trend for a more prolonged wound discharge with OCA. With total hip replacement there was no significant difference between the groups for either early or late complications. Closure of the wound with skin staples was significantly faster than with OCA or suture. There was no significant difference in the length of stay in hospital, Hollander wound evaluation score (cosmesis) or patient satisfaction between the groups at six weeks for either hips or knees. We consider that skin staples are the skin closure of choice for both hip and knee replacements.

Aliment Pharmacol Ther 31, 375-386Aliment Pharmacol Ther 31, 375-386SummaryBackground  The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX®) has been proposed as a novel approach for the treatment of ulcerative colitis (UC).Aim  To assess the efficacy and the tolerability of 8 weeks’ oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable-doses of oral aminosalicylates.Methods  This multicenter, randomized, double-blind proof of concept trial compared the efficacy of CB-01-05 MMX® 210 mg tablets to placebo in 141 subjects with mild to moderately active left-sided UC treated with stable-doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS).Results  A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB-01-05 MMX® group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005).Conclusions  CB-01-05 MMX® was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates.Background  The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX®) has been proposed as a novel approach for the treatment of ulcerative colitis (UC).Aim  To assess the efficacy and the tolerability of 8 weeks’ oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable-doses of oral aminosalicylates.Methods  This multicenter, randomized, double-blind proof of concept trial compared the efficacy of CB-01-05 MMX® 210 mg tablets to placebo in 141 subjects with mild to moderately active left-sided UC treated with stable-doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS).Results  A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB-01-05 MMX® group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005).Conclusions  CB-01-05 MMX® was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates.

Troxacitabine (Troxatyl; BCH-4556; (-)-2'-deoxy-3'-oxacytidine), a deoxycytidine analogue with an unusual dioxolane structure and nonnatural L-configuration, has potent antitumor activity in animal models and is in clinical trials against human malignancies. The current work ...

Copyright ©2010 The Paediatric Research in Emergency Departments International Collaborative (PREDICT) acknowledges the work of the following people in the production of this study protocol et al; licensee BioMed Central Ltd. ... This is an Open Access article distributed under the ...

Rigorous scientific and well-designed clinical trials to evaluate the effect of traditional Chinese medicine (TCM) is lacking. We, therefore, designed this study to evaluate the effectiveness of a commonly used TCM preparation in treating acute cough of uncomplicated URTI in adults and to search for a safe, effective and affordable alternative treatment for this common condition. A randomised, double-blinded, placebo-control study comparing this TCM preparation with a placebo was conducted in 82 patients who attended the Family Medicine Training Centre, Prince of Wales Hospital, Hong Kong between November and December, 2003. The TCM herbal preparation includes nine commonly used TCM herbs for cough such as chuanbei, fangfeng, jiegeng, gancao and baibu (see Table 1). The treatment lasted for 5 days and patients were followed-up for another 6 days. Patients were asked to fill in a cough score and validated Leicester cough questionnaire (LCQ). 62 patients (75.6%) had completed the tria...

Treatment of chronic hepatitis B virus (HBV) infection is aimed at suppressing viral replication to the lowest possible level, and thereby to halt the progression of liver disease and prevent the onset of complications. Two categories of drugs are used in HBV therapy: the interferons, including standard interferon alfa or pegylated interferon alfa, and specific nucleoside or nucleotide HBV inhibitors that target the reverse-transcriptase function of HBV-DNA polymerase. The reported results of clinical trials have used varying definitions of efficacy, failure, and resistance based on different measures of virologic responses. This article discusses HBV virologic markers and tests, and their optimal use both for planning and reporting clinical trials and in clinical practice.

Palliative care aims at improving the patient’s quality of life. The assessment of this quality of life (QoL) is crucial for the evaluation of palliative care outcome. Many patients require hospital admissions for symptom control during their cancer journey and most of them die in hospitals, although they would like to stay at home until the end of their lives. In 1986, the European Organization for Research and Treatment (EORTC) initiated a research programme to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. This questionnaire measures cancer patients’ physical, psychological and social functions and was used in a wide range of clinical cancer trials with large numbers of research groups and also in various other non-trial studies. The aim of this study was to evaluate the psychometric properties, especially the reliability, validity and applicability of the EORTC QLQ-C30 in a German sample of t...

Introduction: Currently, using various combinations of sedative and analgesic agents has received attention for induction of sedation and analgesia due to their synergy in controlling pain and anxiety. The present study was designed with the aim of comparing dexmedetomidine-fentanyl combination with midazolam-fentanyl in this regard. Methods: In this randomized clinical trial, patients diagnosed with distal radius fracture who had visited the emergency department (ED) were allocated to either the group receiving the combination of fentanyl-midazolam or the one receiving dexmedetomidine-fentanyl for procedural sedation and analgesia (PSA) and were compared regarding analgesic characteristics, time to recovery and side effects. Results: 80 patients with the mean age of 42.08 ± 12.17 (18-60) years were randomly allocated to 2 groups of 40 (83.80% male). The 2 groups did not have a significant difference regarding baseline characteristics as well as pain severity. Mean pain score at the time of procedure was 3.47 ± 1.37 in dexmedetomidine and 2.85 ± 1.05 in midazolam group (p = 0.025). In addition, time to recovery in dexmedetomidine and midazolam groups was 6.60 ± 1.86 minutes and 12.70 ± 1.70 minutes, respectively (p < 0.001). Out of the 9 patients who experienced treatment failure, 8 (88.90%) patients were in dexmedetomidine group and 1 (11.10%) was in midazolam group (p = 0.029). Absolute risk increase rate of treatment failure in case of using dexmedetomidine instead of midazolam was 17.50% (95%CI: 4.19 – 30.81) and number needed to harm was 6.00 (95% CI: 3.20 – 23.80). Conclusion: Although the combination of dexmedetomidine-fentanyl had a shorter time to recovery compared to midazolam-fentanyl for induction of sedation and analgesia, the treatment failure rate in case of using dexmedetomidine with 1 µg/kg increased 17.5% and about 1 out of each 6 patients needed a rescue dose.

There is growing interest in the provision of trial results to trial participants. However, there are a number of gaps in the research base relating to the closure of clinical trials and feedback of results to participants.The aim of this research was to explore the practice of feeding back trial results to trial participants and to identify best practice in this area. Postal questionnaires were sent to members of the UK National Cancer Research Institute Clinical Studies Groups (NCRI CSG) and to patients over the age of 18 years who completed trial treatment (located in one Cancer Network) during a 16-month period (April 07–July 08).145 NCRI CSG member surveys and 81 patient questionnaires were returned. The vast majority of all respondents supported the idea of offering results to trial participants. However, NCRI members and trial participants differed in their opinions about the timing and method for the provision of results.The results provide an insight into the views of these groups in relation to desire for results and practical aspects of results feedback which should inform further investigations into trial management and the practice of feedback of trial results.

Children with hyperlipidemia secondary to renal disease develop premature atherosclerosis and glomerulosclerosis. The aims of this pilot study were to find the dosage and short-term efficacy of simvastatin and potential adverse events in children with chronic kidney diseases. This was a random, double-blind, placebo-controlled, cross-over clinical trial performed on children with hyperlipidemia secondary to kidney disorders. After being placed on a diet for 3 months, patients were randomly placed in one of two balanced group blocks and treated with diet plus placebo or simvastatin at doses of 5 mg for children weighing 30 kg or less and 10 mg for children weighing over 30 kg, for 1 month, and then doubled for two more months. After this treatment, patients were placed on a diet for a 3-month washout period. During the last trial phase, patients previously treated with simvastatin were administered a placebo, and vice versa. A total of 25 patients with ages ranging from 4 years to 17 years were included in the study. A significant decrease in the levels of serum cholesterol (26.4%), low-density lipoprotein (LDL) (35.4%) and triglycerides (23.1%) was noted during the study, primarily during the simvastatin treatments, in which case cholesterol, LDL and triglycerides decreased by 23.3%, 33.7% and 21%, respectively. High-density lipoprotein (HDL) levels increased moderately (10.7%) during the study but without differences during simvastatin treatment. No differences were found across groups with respect to adverse events. In the short-term the combination of diet and simvastatin was effective in lowering hyperlipidemia in children with renal disorders.

The aim of this study was to describe the natural history and management of surgically unresectable intra-abdominal desmoid tumors in two patients with Gardner&amp;#39;s syndrome from two unrelated families, where each had failed on conventional therapy. Two patients with Gardner&amp;#39;s syndrome were placed on a chemotherapy regimen which included doxorubicin (90 mg/m2) and dacarbazine (900 mg/m2) in divided doses over four days of continuous infusion. Their progress on chemotherapy was assessed by abdominal computerized tomography and laparoscopy. The computerized abdominal tomography scans proved difficult to interpret because of adhesions and matted small bowel resulting from the patients original colectomies. These findings made it difficult to differentiate postoperative changes from residual desmoid tumor. Second-look laparotomy in such patients was contraindicated as this may predispose to further desmoid production. Laparoscopy disclosed a complete response to this chemotherapy. Nevertheless, we had an iatrogenic small bowel perforation in one of these patients. Each patient showed a complete response to chemotherapy. Surgical resection remains the first-line treatment of intraabdominal desmoid tumors. However, doxorubicin/dacarbazine chemotherapy on a clinical trial basis may be indicated in patients whose intra-abdominal desmoid is unresectable, or who have failed to respond to treatment with hormones (tamoxifen, Toremifene), steroids (prednisone), and nonsteroidal anti-inflammatory agents (Clinoril; Merck &amp;amp; Co., Inc., West Point, PA).