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Pilot Trial (pilot + trial)

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Medical Sciences	96%

Distribution within Medical Sciences

Dermatology	9%
18 Other Subdomains	82%

Selected Abstracts

Highly Purified 1000-cSt Silicone Oil for Treatment of Human Immunodeficiency Virus-Associated Facial Lipoatrophy: An Open Pilot Trial

DERMATOLOGIC SURGERY, Issue 10 2004
Derek H. Jones MD
Background. Among human immunodeficiency virus-infected individuals, facial lipoatrophy has become epidemic. Those affected are stigmatized, leading to psychological distress, social and career impediments, and impaired compliance to human immunodeficiency virus medications. Temporary treatment options are limited by excessive cost, necessity of frequent treatments, and lack of a natural look or feel beneath the skin. Affected patients require more persistent, affordable, safe, and effective treatment options. Objective. The objective was to evaluate the safety and efficacy of highly purified 1000-cSt silicone oil injected by microdroplet serial puncture technique for the treatment of human immunodeficiency virus-associated lipoatrophy. Methods. Data on 77 patients with a complete correction were analyzed to determine the number of treatments, amount of silicone, and time required to reach complete correction, relative to initial severity. Results. The volume of silicone, number of treatments, and time required to reach a complete correction were directly related to initial severity of lipoatrophy (p < 0.0001). Supple, even facial contours were routinely restored, with all patients tolerating treatments well. No adverse events were noted. Conclusion. In this pilot trial, we have demonstrated that highly purified 1000-cSt silicone oil is a safe and effective treatment option for human immunodeficiency virus facial lipoatrophy. Longer-term safety and efficacy in human immunodeficiency virus patients remain to be proven. [source]

A Pilot Trial of the Alpha-1 Adrenergic Antagonist, Prazosin, for Alcohol Dependence

ALCOHOLISM, Issue 2 2009
Tracy L. Simpson
Background:, Current medications for alcohol dependence (AD) show only modest efficacy. None target brain noradrenergic pathways. Theory and preclinical evidence suggest that noradrenergic circuits may be involved in alcohol reinforcement and relapse. We therefore tested the ,-1 adrenergic receptor antagonist, prazosin, as a pharmacotherapy for AD. Methods:, We randomized 24 participants with AD but without posttraumatic stress disorder to receive either prazosin or placebo in a 6-week, double-blind pilot study. Medication was titrated to a target dose of 4 mg QAM, 4 mg QPM, and 8 mg QHS by the end of week 2. Participants received 5 medical management treatment sessions. Participants were reminded 3 times each day via a text pager to take medications and to call a telephone monitoring system once daily to provide self-reports of alcohol consumption and craving, the primary outcome measures. Results were analyzed using mixed linear regression adjusted for drinking days per week at baseline and week number. Results:, Twenty of the 24 (83%) subjects completed. Among the completers, the prazosin group reported fewer drinking days per week than the placebo group during the final 3 weeks of the study. Since only 1 woman was randomized to placebo and only three women completed the trial, the following results focus on the 17 male completers. The prazosin group reported fewer drinking days per week and fewer drinks per week during the final 3 weeks of the study; average total number of drinking days for the placebo group 5.7 (SEM 1.9) versus 0.9 (SEM 0.5) for the prazosin group, and average total number of drinks 20.8 (SEM 6.5) for the placebo group versus 2.6 (SEM 1.3) for the prazosin group. Rates of adverse events were equivalent across conditions. Conclusions:, Prazosin holds promise as a pharmacologic treatment for AD and deserves further evaluation in a larger controlled trial. [source]

Internet-Based Brief Sex Therapy for Heterosexual Men with Sexual Dysfunctions: A Randomized Controlled Pilot Trial

THE JOURNAL OF SEXUAL MEDICINE, Issue 8 2009
Jacques J.D.M. Van Lankveld PhD
ABSTRACT Introduction., Internet-based sex therapy for men with erectile dysfunction has been advocated as an easily accessible and cost-effective treatment. Aim., To test whether Internet-based sex therapy is superior to waiting list. Methods., Internet-based therapy was administered to heterosexual men with erectile dysfunction or premature ejaculation, without face-to-face contact, in a waiting-list controlled design, with pre-, post-, and follow-up measurements at 3 and 6 months posttreatment. Treatment was based on the sensate-focus model of Masters and Johnson, and supplemented with cognitive restructuring techniques. Main Outcome Measures., Self-reported improvement of sexual functioning, erectile functioning (men with ED), premature ejaculation (men with PE), sexual desire, overall sexual satisfaction, and sexual self-confidence. Results., Ninety-eight men participated (58 ED, 40 PE). Sexual functioning was much or somewhat improved in 40 participants (48%). In participants with ED, a near significant effect of treatment was found (P = 0.065), with higher levels of sexual desire (P < 0.05) and sexual self-confidence (P = 0.05) in treated men, in addition to improved erectile functioning (P = 0.01) and overall sexual satisfaction (P < 0.001) in both groups. In participants with PE, treatment was not superior to waiting list. In participants with ED, erectile functioning (P < 0.05) and overall sexual satisfaction (P = 0.002) improved significantly. In participants with PE, latency to ejaculation (P < 0.001), sexual desire (P < 0.05), and overall sexual satisfaction (P < 0.05) improved significantly from baseline to posttreatment, with no further changes at both follow-ups. Sexual self-confidence in men with PE remained unchanged during treatment until follow-up at 3 months posttreatment, and then was found to be improved at 6-months follow-up (P < 0.05). Conclusion., Internet-based sex therapy for male erectile dysfunction was efficacious for male erectile disorder. For men with premature ejaculation, however, treatment was not superior to waiting list. van Lankveld JJDM, Leusink P, van Diest S, Gijs L, and Slob AK. Internet-based brief sex therapy for heterosexual men with sexual dysfunctions: A randomized controlled pilot trial. J Sex Med 2009;6:2224,2236. [source]

Pilot trial of Vedic medicine for type 2 diabetes

FOCUS ON ALTERNATIVE AND COMPLEMENTARY THERAPIES AN EVIDENCE-BASED APPROACH, Issue 2004
C Elder
[source]

Pilot trial of concomitant chemotherapy with paclitaxel and split-course radiotherapy for very advanced squamous cell carcinoma of head and neck,

HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 3 2002
Olavo Feher MD
Abstract Purpose The combination of chemotherapy and irradiation is considered the standard of care for the treatment of advanced squamous cell carcinoma of head and neck (SCCHN). Paclitaxel has shown a single-agent activity in SCCHN. Besides, this drug is a promising radiosensitizer for some human solid tumors. This is a phase II trial to evaluate the feasibility, efficacy, and toxicity of paclitaxel administered concurrently with split-course radiotherapy in advanced unresectable SCCHN. Methods and Materials Thirty-one patients with advanced SCCHN were enrolled in this trial. Radiotherapy consisted of 66 to 70 Gy delivered over 8 to 10 weeks to the primary tumor and lymphatic drainage, with a fractionation scheme of 1.8 to 2 Gy/field/d. After the initial five patients were treated, a 1-week treatment break was introduced. Paclitaxel was administered weekly in a 1-hour intravenous infusion at a projected dosage of 45 mg/m2/wk. Results The complete and partial response rates, based on a 4-week postradiation evaluation were 43.3% and 40%, respectively, with an overall response rate of 83.3%. Median survival was 49.4 weeks, and 1-year survival was 48%. Freedom from local progression was 65.6% at 1 year. Thirty-six percent and 20% of the patients are alive and disease free at 1 and 2 years, respectively. Grade 3/4 of acute toxicity consisted mostly of mucositis, cutaneous reaction, and weight loss. Conclusions Paclitaxel concurrent with radiotherapy seems to be active in squamous cell carcinoma of the head and neck. In the regimen selected for this trial, toxicity was significant and led to a prolongation of treatment time. © 2002 Wiley Periodicals, Inc. Head Neck 24: 228,235, 2002; DOI 10.1002/hed.10049 [source]

Pilot trial: Pioglitazone versus placebo in patients with plaque psoriasis (the P6)

INTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 4 2005
Nusrat Shafiq MD
Background, Disordered differentiation and hyperproliferation of keratinocytes with inflammation are the hallmarks of psoriasis. Ligand activation of peroxisome proliferator receptor-, (a class of nuclear receptors) by thiazolidinediones can normalize the histologic features of psoriasis. Method, In a 10-week, double-blind, randomized, placebo-controlled, parallel-group study, 70 patients with moderate to severe psoriasis received one of the following treatments: pioglitazone 15 mg, pioglitazone 30 mg or placebo. Efficacy was evaluated by observing the change in the psoriasis area and severity index (PASI) after 10 weeks of treatment. Results, There was a dose-dependent improvement in psoriasis. Median PASI scores at the end of 10 weeks were significantly reduced in the pioglitazone treatment groups as compared to the placebo-treated group. The psoriasis lesions cleared in more than 40% of patients treated with pioglitazone as compared to 12.5% of those with placebo. The percentage reduction in mean PASI scores was 21.6%, 41.1% and 47.5% in the placebo, pioglitazone 15 mg, and 30 mg groups, respectively. No serious adverse events were detected. Conclusion, This is the first report from a controlled trial demonstrating that pioglitazone could be considered as an efficacious and safe agent for the treatment of plaque psoriasis. The optimum dose and duration of pioglitazone therapy remain to be determined. [source]

Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis,

ANNALS OF NEUROLOGY, Issue 2 2010
Bruce A. C. Cree MD
Objective To evaluate the efficacy of 4.5mg nightly naltrexone on the quality of life of multiple sclerosis (MS) patients. Methods This single-center, double-masked, placebo-controlled, crossover study evaluated the efficacy of 8 weeks of treatment with 4.5mg nightly naltrexone (low-dose naltrexone, LDN) on self-reported quality of life of MS patients. Results Eighty subjects with clinically definite MS were enrolled, and 60 subjects completed the trial. Ten withdrew before completing the first trial period: 8 for personal reasons, 1 for a non,MS-related adverse event, and 1 for perceived benefit. Database management errors occurred in 4 other subjects, and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated, and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Health Inventory (p < 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvement on the Perceived Deficits Questionnaire (p = 0.05). Interpretation LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted. ANN NEUROL 2010 [source]

Highly Purified 1000-cSt Silicone Oil for Treatment of Human Immunodeficiency Virus-Associated Facial Lipoatrophy: An Open Pilot Trial

Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response,

HEPATOLOGY, Issue 1 2008
Olav Dalgard
A recent nonrandomized pilot trial showed that hepatitis C virus (HCV) patients with genotype 2/3 and rapid virological response (RVR) had a 90% sustained virological response (SVR) rate after 14 weeks of treatment. We aimed to assess this concept in a randomized controlled trial. In the trial, 428 treatment-naïve HCV RNA,positive patients with genotype 2 or 3 were enrolled. Patients with RVR were randomized to 14 (group A) or 24 (group B) weeks of treatment. Patients were treated with pegylated interferon ,-2b (1.5 ,g/kg) subcutaneously weekly and ribavirin (800-1400 mg) orally daily. The noninferiority margin was set to be 10% between the two groups with a one-sided 2.5% significance level. RVR was obtained in 302 of 428 (71%), and 298 of these were randomized to group A (n = 148) or group B (n = 150). In the intention-to-treat analysis, SVR rates were 120 of 148 (81.1%) in group A and 136 of 150 (90.7%) in group B (difference, 9.6%; 95% confidence interval, 1.7-17.7). Among patients with an HCV RNA test 24 weeks after the end of treatment, 120 of 139 (86.3%) patients in group A achieved SVR compared with 136 of 146 (93.2%) in group B (difference, 6.9%; 95% confidence interval, ,0.1 to +13.9). Conclusion: We cannot formally claim that 14 weeks of treatment is noninferior to 24 weeks of treatment. However, the SVR rate after 14 weeks of treatment is high, and although longer treatment may give slightly better SVR, we believe economical savings and fewer side effects make it rational to treat patients with genotype 2 or 3 and RVR for only 14 weeks. (HEPATOLOGY 2007.) [source]

Lopinavir/ritonavir monotherapy as maintenance treatment in HIV-infected individuals with virological suppression: results from a pilot study in Brazil

HIV MEDICINE, Issue 5 2008
E Sprinz
Objective The aim of the study was to evaluate the possibility of using lopinavir/ritonavir (LPV/RTV) alone as maintenance therapy in HIV-infected individuals with virological suppression. Design This was a single-armed single-centre pilot trial. Methods Asymptomatic HIV-infected patients on highly active antiretroviral therapy (HAART) including LPV/RTV, and with plasma HIV RNA <40 copies/mL for at least 6 months, were enrolled in the study, during which they continued with LPV/RTV alone. The intention was to recruit 25 patients to be followed for 2 years. Viral failure was defined as two consecutive HIV RNA measurements >40 copies/mL. Nadir and baseline CD4 cell counts, highest ever HIV RNA load, time with undetectable viraemia before monotherapy, number of previous antiretroviral (ARV) regimens, and gene polymorphism at CYP3A4 and CYP3A5 were evaluated. Results All patients (27) completed the study. Their median age was 43 years, and 66% were men. Ten patients (37%) failed to maintain virological suppression (the median time to HIV rebound was 10.5 months, with a range of 4,23 months). One patient developed full resistance to LPV and another developed neurocognitive impairment while on LPV/RTV which improved after HAART reintroduction. There were no differences between failures and nonfailures according to the analysed parameters. Patients with viral failure were successfully resuppressed. Conclusions LPV/RTV maintenance therapy was associated with 37% failure, a higher than expected failure rate. In order to ensure that unnecessary risks are not being taken in patients on LPV/RTV, this finding should be further evaluated in large randomized trials for longer periods of follow-up. [source]

Efficacy of amisulpride in treating primary negative symptoms in first-episode psychosis: a pilot study

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 8 2006
Brendan P. Murphy
Abstract Objective Negative symptoms are debilitating and associated with poor role functioning and reduced quality of life. There is a paucity of research on antipsychotic efficacy against the primary negative symptoms, particularly in first-episode psychosis (FEP). We undertook a prospective, open-label pilot trial to investigate the use of amisulpride in the treatment of young people with FEP characterised by primary negative symptoms. Method Twelve male and two female first-episode patients with primary negative symptoms (aged 16,26) were commenced on low-dose amisulpride (mean 250,mg/day) and followed-up over a 6-month period. Primary outcome measures were the Scale for the Assessment of Negative Symptoms (SANS), the Quality of Life Survey (QLS) and their respective subscales. Results For the 12 completers there was a statistically significant improvement in SANS summary score (p,=,0.036), Affective Flattening subscale global score (p,=,0.046), QLS total score (p,=,0.021), QLS subscales of Instrumental Role (p,=,0.018) and Intra-psychic Foundations (p,=,0.009) from baseline to week 24. Conclusions Amisulpride appears to be associated with less severe negative symptoms and improved quality of life. Generalisabilty of the findings is limited by the small sample size and open-label design of our study, however the positive findings suggest that further controlled trials are warranted. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Meditation with yoga, group therapy with hypnosis, and psychoeducation for long-term depressed mood: a randomized pilot trial

JOURNAL OF CLINICAL PSYCHOLOGY, Issue 7 2008
Lisa D. Butler
Abstract This randomized pilot study investigated the effects of meditation with yoga (and psychoeducation) versus group therapy with hypnosis (and psychoeducation) versus psychoeducation alone on diagnostic status and symptom levels among 46 individuals with long-term depressive disorders. Results indicate that significantly more meditation group participants experienced a remission than did controls at 9-month follow-up. Eight hypnosis group participants also experienced a remission, but the difference from controls was not statistically significant. Three control participants, but no meditation or hypnosis participants, developed a new depressive episode during the study, though this difference did not reach statistical significance in any case. Although all groups reported some reduction in symptom levels, they did not differ significantly in that outcome. Overall, these results suggest that these two interventions show promise for treating low- to moderate-level depression. © 2008 Wiley Periodicals, Inc. J Clin Psychol 64(7): 1,15, 2008. [source]

Diabetic foot ulcer burden may be modified by high-dose atorvastatin: A 6-month randomized controlled pilot trial

JOURNAL OF DIABETES, Issue 3 2009
Odd Erik JOHANSEN
Abstract Background:, Diabetic foot ulcers (DFUs) are common complications of diabetes mellitus (DM), with a complex pathogenesis. Treatment is difficult and no single treatment with measurable clinical impact is available. In the present clinical pilot trial, we investigated whether statins could be of use against some of the pathogenic factors in DFUs. Methods:, Thirteen diabetic patients (10 men; 11 with Type 2 DM; mean age 64 years; mean duration of DM 18 years) with neuropathic DFUs <4 months were randomized to treatment with either 10 mg (six patients; six ulcers) or 80 mg (seven patients; nine ulcers) atorvastatin for 6 months in addition to conventional DFU care (i.e. prompt debridement, DFU pressure relief, and management of any underlying infection). Results:, There were no significant differences in background factors (i.e. HbA1c 8.9%, micro- and macrovascular complications, concomitant medications) or DFU characteristics (duration, surface area, grading) between the two groups. All ulcers in the group receiving 10 mg atorvastatin healed, compared with six of nine ulcers in the group receiving 80 mg atorvastatin (NS). However, two previously healed DFUs recurred and six new DFUs developed in the low-dose group compared with none and one, respectively, in the high-dose group (P = 0.048). There was a significant decrease in C-reactive protein (,1.5 mg/L; P = 0.044) and a non-significant trend towards beneficial effects on lipids and the ankle,arm blood pressure index in the high-dose compared with the low-dose group. Conclusions:, We observed a possible beneficial effect of 6-months high-dose atorvastatin on DFUs, which should be tested in appropriately sized prospective studies. [source]

Short-term effects of a mandibular advancement device on obstructive sleep apnoea: an open-label pilot trial

JOURNAL OF ORAL REHABILITATION, Issue 8 2005
G. AARAB
summary, Obstructive sleep apnoea (OSA) is a common sleep disorder, which is, among others, associated with snoring. OSA has a considerable impact on a patient's general health and daily life. Nasal continuous positive airway pressure (nCPAP) is frequently used as a ,gold standard' treatment for OSA. As an alternative, especially for mild/moderate cases, mandibular advancement devices (MADs) are prescribed increasingly. Their efficacy and effectiveness seem to be acceptable. Although some randomized clinical trials (RCTs) have been published recently, most studies so far are case studies. Therefore, our department is planning a controlled RCT, in which MADs are compared with both nCPAP and a control condition in a parallel design. As a first step, an adjustable MAD was developed with a small, more or less constant vertical dimension at different mandibular positions. To test the device and the experimental procedures, a pilot trial was performed with 10 OSA patients (six mild, four moderate; one women, nine men; mean age = 47·9 ± 9·7 years). They all underwent a polysomnographic recording before as well as 2,14 weeks after insertion of the MAD (adjusted at 50% of the maximal protrusion). The apnoea,hypopnoea index (AHI) was significantly reduced with the MAD in situ (P = 0·017). When analysed as separate groups, the moderate cases showed a significantly larger decrease in AHI than the mild cases (P = 0·012). It was therefore concluded from this pilot study that this MAD might be an effective tool in the treatment of, especially, moderate OSA. [source]

Treatment of Helicobacter pylori infection with intra-gastric violet light phototherapy: A pilot clinical trial,

LASERS IN SURGERY AND MEDICINE, Issue 5 2009
Anthony J. Lembo MD
Abstract Background and Objective Helicobacter pylori infects the mucus layer of the human stomach and causes peptic ulcers and adenocarcinoma. We have previously shown that H. pylori accumulates photoactive porphyrins making the organism susceptible to inactivation by light, and that small spot endoscopic illumination with violet light reduced bacterial load in human stomachs. This study assessed the feasibility and safety of whole-stomach intra-gastric violet phototherapy for the treatment of H. pylori infection. Study Design/Materials and Methods A controlled, prospective pilot trial was conducted using a novel light source consisting of laser diodes and diffusing fibers to deliver 408-nm illumination at escalating total fluences to the whole stomach. Eighteen adults (10 female) with H. pylori infection were treated at three U.S. academic endoscopy centers. Quantitative bacterial counts were obtained from biopsies taken from the antrum, body, and fundus, and serial urea breath tests. Results The largest reduction in bacterial load was in the antrum (>97%), followed by body (>95%) and fundus (>86%). There was a correlation between log reduction and initial bacterial load in the antrum. There was no dose,response seen with increasing illumination times. The urea breath test results indicated that the bacteria repopulated in days following illumination. Conclusion Intra-gastric violet light phototherapy is feasible and safe and may represent a novel approach to eradication of H. pylori, particularly in patients who have failed standard antibiotic treatment. This was a pilot study involving a small number of patients. Further research is needed to determine if phototherapy can be effective for eradicating H. pylori. Lasers Surg. Med. 41:337,344, 2009. © 2009 Wiley-Liss, Inc. [source]

Erratum: Safety of radiofrequency treatment over human skin previously injected with medium-term injectable soft-tissue augmentation materials: A controlled pilot trial

LASERS IN SURGERY AND MEDICINE, Issue 5 2007
Murad Alam MD
In this original published article, Dr. Pajvani's name was misprinted. It should be Urvi Pajvani, MD. [source]

Efficacy and tolerability of a new formulation of sodium phosphate tablets (INKP-101), and a reduced sodium phosphate dose, in colon cleansing: a single-center open-label pilot trial

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2005
M. Khashab
Summary Background :,The tablet form of sodium phosphate for bowel preparation for colonoscopy contains microcrystalline cellulose. This inactive ingredient produces a residue that obscures mucosal visualization and is time-consuming to remove during colonoscopy. Aim :,To perform an open-label study of efficacy and tolerability of a modified formulation with microcrystalline cellulose reduced by 50% (code named INKP-101) and a lower total dose of sodium phosphate. Methods :,Patients scheduled for colonoscopy self-administered 28 INKP-101 tablets (42 g sodium phosphate). Colon cleansing efficacy was evaluated using a standard 4-point scoring system and the amount of microcrystalline cellulose present and time spent removing it using an 8-point scale. Results :,A total of 31 patients were screened and enrolled. Thirty patients had a colonoscopy and were evaluated for colon cleansing efficacy. Overall colon cleansing was rated as excellent and good in 90% and 10% of patients respectively. About 77% of patients had microcrystalline cellulose scores of 2 or 3 (corresponding to <1 or 1,2 min spent removing microcrystalline cellulose, respectively). The drug was well-tolerated and adverse events were generally benign. Conclusion :,A new formulation of sodium phosphate with reduced microcrystalline cellulose and a lower total dose of sodium phosphate was effective for colonoscopy and well-tolerated. [source]

A Pilot Study Investigating the Effects of Fast Left Prefrontal rTMS on Chronic Neuropathic Pain

PAIN MEDICINE, Issue 5 2009
Jeffrey J. Borckardt PhD
ABSTRACT Objective., Stimulating the human cortex using transcranial magnetic stimulation (TMS) temporarily reduces clinical and experimental pain; however, it is unclear which cortical targets are the most effective. The motor cortex has been a popular target for managing neuropathic pain, while the prefrontal cortex has been investigated for an array of nociceptive pain conditions. It is unclear whether the motor cortex is the only effective cortical target for managing neuropathic pain, and no published studies to date have investigated the effects of prefrontal stimulation on neuropathic pain. Design., This preliminary pilot trial employed a sham-controlled, within-subject, crossover design to evaluate clinical pain as well as laboratory pain thresholds among four patients with chronic neuropathic pain. Each participant underwent three real and three sham 20-minute sessions of 10 Hz left prefrontal repetitive TMS. Daily pain diaries were collected for 3 weeks before and after each treatment phase along with a battery of self-report pain and mood questionnaires. Results., Time-series analysis at the individual patient level indicated that real TMS was associated with significant improvements in average daily pain in 3 of the 4 participants. These effects were independent of changes in mood in two of the participants. At the group level, a decrease of 19% in daily pain on average, pain at its worst, and pain at its least was observed while controlling for changes in mood, activity level and sleep. The effects of real TMS were significantly greater than sham. Real TMS was associated with increases in thermal and mechanical pain thresholds, whereas sham was not. No statistically significant effects were observed across the questionnaire data. Conclusions., The prefrontal cortex may be an important TMS cortical target for managing certain types of pain, including certain neuropathic pain syndromes. [source]

Intervertebral Disc Biacuplasty for the Treatment of Lumbar Discogenic Pain: Results of a Six-Month Follow-Up

PAIN MEDICINE, Issue 1 2008
Leonardo Kapural MD
ABSTRACT Objective., Intradiscal biacuplasty (IDB) is a novel bipolar cooled radiofrequency system for the treatment of degenerative disk disease. We present the results of a pilot trial with 6-month follow-up. Design, Setting, Patients, and Interventions., Fifteen patients, 22,55 years old, underwent one- or two-level IDB treatment of their painful lumbar discs. All had chronic low back pain >6 months, back pain exceeding leg pain, concordant pain on provocative discography, disc height >50% of control, and evidence of single- or two-level degenerative disc disease without evidence of additional changes on magnetic resonance imaging. IDB was performed under fluoroscopy using two radiofrequency probes positioned bilaterally in the intervertebral disc. Thirteen patients completed follow-up questionnaires at 1, 3, and 6 months. Pain disability was evaluated with Oswestry and Short Form (SF)-36 questionnaires. Results., Median visual analog scale pain scores were reduced from 7 (95% confidence interval [CI] 6, 8) to 4 (2, 5) cm at 1 month, and remained at 3 (2, 5) cm at 6 months. The Oswestry improved from 23.3 (SD 7.0) to 16.5 (6.8) points at 1 month and remained similar after 6 months. The SF-36 Physical Functioning scores improved from 51 (18) to 70 (16) points after 6 months, while the SF-36 Bodily Pain score improved from 38 (15) to 54 (23) points. Daily opioid use did not change significantly from baseline: from 40 (95% CI 40, 120) before IDB to 5 (0, 40) mg of morphine sulfate equivalent 6 months after IDB. No procedure-related complications were detected. Conclusions., Patients showed improvements in several pain assessment measures after undergoing IDB for discogenic pain. A randomized controlled study is warranted and needed to address the efficacy of the procedure. [source]

Development of 2-hour suicide intervention program among medical residents: First pilot trial

PSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 5 2010
Takahiro A. Kato MD
Aim:, Suicide is associated not only with primary psychiatric disorders but also with physical disorders. Physicians' education on suicide prevention contributes to reducing suicide. Therefore, medical residents, who contact patients daily and who eventually become primary physicians in each specialty, might be the most appropriate candidates for intervention. In this article, we introduce our newly developed suicide intervention program among medical residents. Methods:, We developed a 2-hour suicide intervention program among medical residents, based on the Mental Health First Aid (MHFA), which had originally been developed for the public. The program contains a 1-hour lecture and a 1-hour role-play session. As the first pilot trial, we conducted the program among 44 first-year medical residents at a university hospital and evaluated its effectiveness. Changes in confidence, attitudes and behavior toward suicidal people were evaluated using self-reported questionnaires before, immediately after, and 6 months after the program. Results:, Participants' confidence and attitudes significantly improved after the program. The total mean score (standard deviation) of the Suicide Intervention Response Inventory improved from 18.4 (2.0) before the intervention to 19.4 (2.0) immediately after the intervention. However, the effectiveness was limited after 6 months. In the course of 6 months, the participants learned to apply the MHFA principles in their daily clinical practice. Conclusion:, Our newly developed brief suicide intervention program demonstrating its effectiveness among medical residents should be modified in order to be more effective in the long term. The next trial with a control group ought to be conducted to evaluate our developed program. [source]

Internet-Based Brief Sex Therapy for Heterosexual Men with Sexual Dysfunctions: A Randomized Controlled Pilot Trial

Intensive and Prolonged Treatment of Focal and Segmental Glomerulosclerosis Recurrence in Adult Kidney Transplant Recipients: A Pilot Study

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 5 2009
G. Canaud
No treatment has consistently induced long-term remission of proteinuria in adult patients with focal segmental glomerulosclerosis (FSGS) recurrence after kidney transplantation. We undertook an open-label, nonrandomized pilot trial of intensive and prolonged treatment of FSGS recurrence. Over an 18-month period, 10 adult kidney transplant recipients with FSGS recurrence received concomitantly high-dose steroids, intravenous cyclosporine for 14 days followed by oral cyclosporine therapy, and an intensive and prolonged course of plasma exchanges (PE). We compared this treatment with those of a control group of 19 patients with a FSGS recurrence transplanted between 1997 and 2005. Complete, rapid (mean 23 ± 7 days) and sustained remission was obtained in 9/10 patients (90%) as opposed to 27% in the control group. At month 3 and month 12, proteinuria was 0.16 g/day (range 0.05,0.3 g/day) and 0.19 g/day (range 0.05,1 g/day) respectively. Only one patient remained in partial remission at month 12 but he had already lost two previous grafts due to FSGS recurrence. PEs were stopped at month 9 in all patients except for the patient with a partial remission who remains PE-dependent. This small pilot study provides very encouraging results demonstrating that this treatment rapidly achieves complete and sustained remission in a high proportion of patients. [source]

GOAL ATTAINMENT SCALING: AN EFFECTIVE OUTCOME MEASURE FOR RURAL AND REMOTE HEALTH SERVICES

AUSTRALIAN JOURNAL OF RURAL HEALTH, Issue 5 2002
Ruth Cox
ABSTRACT: The aim of this paper is to demonstrate the utility of Goal Attainment Scaling (GAS) as an effective, multidisciplinary measure of client outcomes for rural and remote health services. Goal Attainment Scaling was adopted by the Spinal Outreach Team (SPOT) as a client-focussed evaluation tool, as it is sensitive to the individual nature of clients' presenting issues and the multidisciplinary focus of the team. It enables individualised goals to be set on a five-point scale. Goal Attainment Scaling was introduced to the SPOT service after a pilot trial established guidelines for its effective implementation. An ongoing review process ensures that goal scaling remains realistic and relevant. Service outcomes can be effectively summarised using a frequency distribution of GAS scores. One of the important benefits of GAS is its facilitation of collaborative goal setting between clinician and client. Goal Attainment Scaling is recommended to rural and remote multidisciplinary health services because of its ability to summarise outcomes from heterogeneous service activities. [source]

A phase 2 pilot trial of low-dose, continuous infusion, or "metronomic" paclitaxel and oral celecoxib in patients with metastatic melanoma

CANCER, Issue 7 2010
Rupal S. Bhatt MD
Abstract BACKGROUND: Tumor angiogenesis has been associated with a poor prognosis in patients with metastatic melanoma (MM). Microtubule stabilizers and cyclooxygenase 2 (COX-2) inhibitors, alone and in combination, have produced inhibitory effects on endothelial cells and tumor angiogenesis. Angiogenesis, which is the growth of new blood vessels, is necessary for tumor growth and progression. Thus, the authors tested the safety and efficacy of a low dose of paclitaxel and celecoxib in patients with MM. METHODS: Patients received paclitaxel 10 mg/m2 for 96 hours weekly as a continuous intravenous infusion and oral celecoxib 400 mg twice daily. Systemic tumor response was assessed at 6-week intervals. Tumor measurements at the end of Cycle 1 were used as the baseline for assessment of tumor progression. Patients with unacceptable toxicity or disease progression after Cycle 2 relative to the end of Cycle 1 were taken off study. RESULTS: Twenty patients were enrolled. Twelve of 20 patients (60%) had received ,2 previous systemic therapies. Three patients did not receive treatment because of rapid disease progression. Treatment-related grade 3/4 toxicities were limited to catheter-related complications. One patient achieved a partial response, and 3 of 20 patients (15%) had stable disease for >6 months. The median time to progression was 57 days (95% confidence interval, 43-151 days), and the median overall survival was 212 days (95% confidence interval, 147-811 days). CONCLUSIONS: Low-dose, continuous intravenous infusion paclitaxel and oral celecoxib produced disease stabilization in a significant proportion of heavily pretreated patients with MM. These findings support a role for metronomic therapy in patients with this disease. Cancer 2010. © 2010 American Cancer Society. [source]

Adoptive immunotherapy with allogeneic Epstein,Barr virus (EBV)-specific cytotoxic T-lymphocytes for recurrent, EBV-positive Hodgkin disease

CANCER, Issue 9 2004
Kenneth G. Lucas M.D.
Abstract BACKGROUND It has been shown that adoptive immunotherapy with Epstein,Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) is effective for the treatment of EBV-induced lymphoproliferative disease in stem cell transplantation recipients and organ transplantation recipients. The role of EBV CTL in other tumors for which this virus has been implicated in pathogenesis, such as EBV-positive Hodgkin disease (HD), has not been demonstrated clearly. METHODS To investigate the antitumor effects and toxicity of allogeneic EBV CTL in EBV-positive HD, the authors initiated a pilot trial in which EBV CTL were cultured from allogeneic, partially human leukocyte antigen-matched donors and were infused into patients who had therapy-refractory disease. The first cohort of 3 patients (Cohort I) received 3 separate infusions of EBV CTL (5.0 × 106 EBV CTL/kg per dose), and the second cohort (Cohort II) received 30 mg/m2 per day of fludarabine for 3 days followed by a single CTL infusion (1.5 × 107 EBV CTL/kg). RESULTS All three patients in Cohort I had decreases in measurable disease after EBV CTL infusions, and one of those patients was without evidence of disease 22 months after infusion. Two of 3 patients in Cohort II had decreases in measurable disease, although it was not determined whether those decreases were related to fludarabine or to CTL, and 1 patient in Cohort II had 7 months without disease progression. Unlike the patients in Cohort I, fludarabine recipients did not have increases in antidonor CTL responses. Donor cells could not be detected in any of the CTL recipients. CONCLUSIONS Adoptive immunotherapy with allogeneic EBV CTL was safe for patients with recurrent, refractory, EBV-positive HD; and clinical responses may be observed without the establishment of detectable donor lymphoid chimerism. Cancer 2004. © 2004 American Cancer Society. [source]

Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial)

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2006
Wes R. Pedersen MD
Abstract Objectives: We wished to determine the feasibility and early safety of external beam radiation therapy (EBRT) used following balloon aortic valvuloplasty (BAV) to prevent restenosis. Background: BAV for calcific aortic stenosis (AS) has been largely abandoned because of high restenosis rates, i.e., > 80% at 1 year. Radiation therapy is useful in preventing restenosis following vascular interventions and treating other benign noncardiovascular disorders. Methods: We conducted a 20-patient, pilot study evaluating EBRT to prevent restenosis following BAV in elderly patients with calcific AS. Total doses ranging from 12,18 Gy were delivered in fractions over a 3,5 day post-op period to the aortic valve. Echocardiography was performed pre and 2 days post-op, 1, 6, and 12 months following BAV. Results: One-year follow-up is completed (age 89 ± 4). There were no complications related to EBRT. Eight patients died prior to 1 year; 5 of 10 (50%) in the low-dose (12 Gy) group and 3 of 10 (30%) in the high-dose (15,18 Gy) group. None of these 8 patients had restenosis, i.e., > 50% loss of the initial AVA gain, and only three deaths were cardiac in origin. One patient underwent aortic valve replacement and none repeated BAV. By 1 year, 3 of the initial 10 (30%) in the low-dose group and 1 of 9 (11%) in the high-dose group demonstrated restenosis (21% overall). Conclusions: EBRT following BAV in elderly patients with AS is feasible, free of early complications, and holds promise in reducing the 1 year restenosis rate in a dose-dependent fashion. © 2006 Wiley-Liss, Inc. [source]

A clinical pilot trial of metoclopramide therapy for gastric residuals in preterm infants

ACTA PAEDIATRICA, Issue 8 2007
D Harlev
No abstract is available for this article. [source]

Maternal consumption of dairy products during pregnancy and lactation, and the development of cow's milk antibodies in the offspring

ACTA PAEDIATRICA, Issue 6 2005
Maijaliisa Erkkola
Abstract Objective: To assess whether the maternal consumption of milk and milk products affects development of cow's milk (CM) antibodies in infants. Design: A randomized pilot trial using food frequency questionnaires (mothers) and food records (infants). Setting: Families with a newborn infant with increased HLA-DQB1-conferred risk of type 1 diabetes and at least one first-degree relative affected by type 1 diabetes from 16 hospitals in Finland between April 1995 and November 1997. Subjects and intervention: Infants randomized to receive a hydrolysed formula when breast milk was not available during their first 6,8 mo (n=112). Of these, 13 dropped out by the age of 3 mo and two were excluded due to incomplete CM antibody data. Results: Maternal milk protein intake from cheese during pregnancy was inversely related to IgA-class antibody titres to beta-lactoglobulin (BLG) and casein (CAS) at 3 mo, and to IgA antibody titres to BLG at 6 mo. Maternal consumption of raw milk products during lactation was positively related to the development of IgA antibody titres to CAS at 6 mo, and inversely correlated to IgG antibody titres to bovine serum albumin (BSA) and IgA antibody titres to CAS at 2 y. Maternal cheese consumption was inversely related to the IgG antibody titres to CM formula and CAS and to the IgA antibody titres to CAS in early infancy. Conclusions: Few associations were established between maternal CM protein intake and CM protein antibody levels in the infants. The milk and milk products taken by the mother differed in their impact on the emerging CM antibody response in the offspring. [source]