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Open-label Pilot Study (open-label + pilot_study)

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Medical Sciences	100%

Selected Abstracts

Nonimmersive Virtual Reality Mirror Visual Feedback Therapy and Its Application for the Treatment of Complex Regional Pain Syndrome: An Open-Label Pilot Study

PAIN MEDICINE, Issue 4 2010
Kenji Sato MD
Abstract Objective., Chronic pain conditions such as phantom limb pain and complex regional pain syndrome are difficult to treat, and traditional pharmacological treatment and invasive neural block are not always effective. Plasticity in the central nervous system occurs in these conditions and may be associated with pain. Mirror visual feedback therapy aims to restore normal cortical organization and is applied in the treatment of chronic pain conditions. However, not all patients benefit from this treatment. Virtual reality technology is increasingly attracting attention for medical application, including as an analgesic modality. An advanced mirror visual feedback system with virtual reality technology may have increased analgesic efficacy and benefit a wider patient population. In this preliminary work, we developed a virtual reality mirror visual feedback system and applied it to the treatment of complex regional pain syndrome. Design., A small open-label case series. Five patients with complex regional pain syndrome received virtual reality mirror visual feedback therapy once a week for five to eight sessions on an outpatient basis. Patients were monitored for continued medication use and pain intensity. Results., Four of the five patients showed >50% reduction in pain intensity. Two of these patients ended their visits to our pain clinic after five sessions. Conclusion., Our results indicate that virtual reality mirror visual feedback therapy is a promising alternative treatment for complex regional pain syndrome. Further studies are necessary before concluding that analgesia provided from virtual reality mirror visual feedback therapy is the result of reversing maladaptive changes in pain perception. [source]

N -Acetylcysteine (NAC) in Young Marijuana Users: An Open-Label Pilot Study

THE AMERICAN JOURNAL ON ADDICTIONS, Issue 2 2010
Kevin M. Gray MD
No abstract is available for this article. [source]

Open-label pilot study of folic acid in patients with nonalcoholic steatohepatitis

LIVER INTERNATIONAL, Issue 2 2007
Phunchai Charatcharoenwitthaya
Abstract: Background/Aims: Folate deficiency disturbs hepatic methionine metabolism and promotes the development of steatohepatitis in animal models. Our aims were (1) to determine the safety and efficacy of folic acid treatment in patients with nonalcoholic steatohepatitis (NASH) on changes in liver biochemistries, and (2) to investigate the presence of subclinical folate deficiency in this population. Methods: Patients with biopsy-proven NASH were treated with folic acid 1 mg/day for 6 months. Liver enzymes and adverse events were monitored every 3 months until completion. Results: Ten patients (one male and nine females) with a median age of 54 years were enrolled in this study. At baseline, the median steatosis grade was 2 (range 1,3), the median necroinflammatory grade was 1 (1,3), and the median fibrosis stage was 2 (0,4). The median level of red cell folate was 526 ng/ml (range 99,708); the normal level was 268,616 ng/ml. One compensated cirrhotic patient had folate deficiency. No serious adverse events occurred. After 6 months of therapy, no significant reductions in serum aspartate and alanine aminotransferase levels (60±25 vs. 54±29, P=0.5 and 86±29 vs. 83±42, P=0.6, respectively), were observed. Serum levels of bilirubin, alkaline phosphatase, albumin, and prothrombin time remained in the normal range during treatment in all patients. Conclusion: Six months of therapy with folic acid at a dose of 1 mg/day, although safe and well tolerated, does not lead to a significant biochemical improvement in patients with NASH. In a small number of patients, folate deficiency was present in only a cirrhotic patient. [source]

Open-label pilot study of levetiracetam (Keppra) for the treatment of chorea in Huntington's disease

MOVEMENT DISORDERS, Issue 11 2006
FAAN, Theresa A. Zesiewicz MD
Abstract The objective of this study is to evaluate the tolerability and preliminary efficacy of levetiracetam (LEV) in reducing chorea in Huntington's disease (HD) patients in a prospective open-label pilot study. Nine HD patients with chorea were treated with LEV in doses up to 3,000 mg/day for up to 48 days. The primary endpoint measure was the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore. The mean dose (±SD) of LEV at endpoint was 2,583.3 ± 1,020.6 mg/day. Mean UHDRS chorea score decreased from 12.6 ± 3.0 at baseline to 6.7 ± 4.3 at endpoint (P = 0.01). There was no significant change in UHDRS total motor scores (38.8 ± 11.4 at baseline and 33.6 ± 26.7 at endpoint; P = 0.24). Somnolence contributed to a 33% drop-out rate, and 3 patients developed Parkinsonism. Results of this open label study suggest that LEV may be efficacious in reducing chorea in HD patients. © 2006 Movement Disorder Society [source]

An open-label pilot study using thioguanine as a therapeutic alternative in Crohn's disease patients resistant to 6-mercaptopurine therapy

INFLAMMATORY BOWEL DISEASES, Issue 3 2001
Dr. Marla C. Dubinsky
Abstract Background and Aims A substantial number of patients with inflammatory bowel disease (IBD) fail to achieve a complete clinical response with 6-mercaptopurine (6-MP) and azathioprine (AZA). Inability to achieve therapeutic 6-thioguanine nucleotide (6-TGN) levels due to the preferential overproduction of 6-methylmercaptopurine ribonucleotides (6-MMPR) upon dose escalation characterizes a newly described subgroup of IBD patients resistant to 6-MP/AZA therapy. Treatment with 6-thioguanine (6-TG), a related thiopurine, which forms 6-TGNs more directly may be beneficial in such patients. This pilot study evaluated the safety, tolerance, and efficacy of 6-TG in the subgroup of Crohn's disease (CD) patients failing to attain adequate disease control with traditional 6-MP/AZA therapy. Methods Ten CD patients with preferential 6-MMPR production upon 6-MP/AZA dose escalation were enrolled in an open-label pilot study. Seven of 10 patients had experienced dose-related 6-MP toxicities. Results Seventy percent of the patients (7 of 10) responded or were in remission at week 16. Clinical response was evident by week 4 in most. 6-TGN levels were nine-fold higher with 6-TG treatment than with 6-MP, whereas 6-MMPR levels were undetectable. No patient developed a recurrence of hepatic or hematological toxicity. Conclusions 6-TG was a safer and more efficacious thiopurine in this subgroup of IBD patients resistant to 6-MP therapy. Larger controlled trials are warranted to further evaluate both the short-and long-term safety and efficacy in this subgroup of patients as well as a broader spectrum of IBD patients. [source]

Open-label pilot study of levetiracetam (Keppra) for the treatment of chorea in Huntington's disease

Pilot study: The effect of reducing treatment on exercise induced bronchoconstriction,

PEDIATRIC PULMONOLOGY, Issue 9 2010
E.T.G. Kersten MD
Abstract Rationale Asthma therapy should be stepped up or stepped down in response to changes in asthma control. However, there is little evidence available on the optimal timing, sequence, and degree of medication reductions. In this study we analyzed clinically stable asthmatic children who underwent a medication reduction from a combination preparation consisting of an inhaled corticosteroid (ICS) and long acting beta2-agonist (LABA) to monotherapy with the same dose of the ICS. We hypothesized that the extent of exercise-induced bronchoconstriction (EIB) would not increase after the cessation of the LABA. Methods Nineteen children, aged 8,16 years, with clinically stable asthma, receiving LABA/ICS combination therapy, were analyzed in this open-label pilot study. Children performed an exercise challenge at baseline and 3 weeks after the medication reduction. Best values of spirometric measurements of the forced expiratory volume in 1,sec (FEV1) were used for statistical calculations. Results Maximum percent fall in FEV1 was significantly lower after 3 weeks of ICS monotherapy (P,=,0.03). Eight of 19 children had a ,15% fall in FEV1 after exercise at the initial exercise challenge. In this subgroup, maximum percent fall in FEV1 after the medication reduction was significantly lower (P,<,0.01), and in six children it decreased to <15%, indicating they no longer had EIB. Conclusion In clinically stable asthmatic children on LABA/ICS combination therapy, the cessation of the LABA can reduce and in most cases abolish EIB. Pediatr. Pulmonol. 2010; 45:927,933. © 2010 Wiley-Liss, Inc. [source]

Rituximab in the adjuvant treatment of pemphigus vulgaris: a prospective open-label pilot study in five patients

BRITISH JOURNAL OF DERMATOLOGY, Issue 5 2007
M.S.Y. Goh
Summary Background, Rituximab is a monoclonal antibody directed against the CD20 antigen expressed on B lymphocytes. There are reports of its efficacy in the treatment of autoimmune diseases, including pemphigus. Objectives, Prospectively to evaluate the efficacy of rituximab as adjuvant treatment for pemphigus vulgaris (PV). Methods, Patients with PV were treated with intravenous rituximab (375 mg m,2) weekly for 4 weeks in this prospective open-label pilot study. Other concurrent immunosuppression was continued. Results, Of five patients, one achieved complete remission and was able to cease all medication, while two achieved clearance of clinical lesions but continued on systemic therapy. Two patients had progressive disease. Time to response was 2,8 months, with a 13- to 18-month response duration. Response was associated with reduction in serum antiepithelial antibodies. Two patients had significant infectious complications (one developed community-acquired pneumonia associated with delayed-onset neutropenia and the other developed cytomegalovirus infection). Conclusions, Rituximab has shown efficacy in the treatment of PV. Patients on multiple immunosuppressives should be closely monitored for infectious complications. [source]

EFFECTS OF THE NOVEL SYMBIOTIC IMMUBALANCE AS A FOOD SUPPLEMENT IN RELIEVING CLINICAL SYMPTOMS OF JAPNESE CEDAR POLLINOSIS: A PILOT STUDY

CLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 2007
Yukio Otsuka
SUMMARY 1Probiotics have been suggested to have potential for treating food allergy in small children. Although oral probiotics have been studied extensively in animals and humans for various allergies, their effects on the prevention and/or treatment of pollinosis have not been adequately investigated. 2The aim of the present study was to examine the effects of the novel symbiotic food supplement ImmuBalance (a koji fungus (Aspergillus oryzae) and lactic acid bacteria (Pediococcus parvulus and Enterococcus faecium) soybean fermentation product; Nichimo Co. Ltd, Tokyo, Japan) on the prevention and treatment of allergic reactions in Japanese cedar pollinosis (JCP) during the pollen season. 3An open-label pilot study on seven individuals with JCP was conducted. Each participant received oral administration of 1.0,2.0 g ImmuBalance daily for 3 months, which contained 1.8 ¥ 1010/g heat-killed lactobacteria. Six participants (four men, two women; 26,55 years of age) completed the 3 months of supplementation. One participant was excluded from the study because the JCP-specific IgE in RAST scores was lower than 2 UA/mL. The clinical severity of JCP in past year for each participant was self-evaluated on a five-point scale from 0 to 4, in accordance with the guidelines of the Nasal Allergy Clinic 2002, Japan. 4Self-evaluated overall average symptom scores (1.7 ± 0.8) in the peak pollen season showed significant improvement compared with the past year (3.5 ± 0.5; P = 0.001). Furthermore, the average scores for sneezing and runny nose in the peak pollen season showed significant improvement compared with the past year. The scores for swelling and colour of the mucosa and snivel in the nasal cavity did not increase significantly in the peak pollen season compared with baseline. 5Our studies suggest that dietary ImmuBalance may be effective in the prevention and treatment of JCP. The underlying mechanisms of action and the possibility of a randomized, placebo-controlled trial are being investigated. [source]