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Clinical Study (clinical + study)
Kinds of Clinical Study Selected AbstractsCLINICAL STUDY: FULL ARTICLE: Immunomodulating properties of gamma-hydroxybutyrate (GHB), flunitrazepam and ethanol in ,club drugs' usersADDICTION BIOLOGY, Issue 3 2010Simona Pichini ABSTRACT Despite the increasing concern about gamma-hydroxybutyrate (GHB) toxicity in users, no studies have addressed GHB and other club drugs effects on the immune system under controlled administration. Lymphocyte subsets and functional responsiveness of lymphocytes to mitogenic stimulation were measured in 10 healthy male recreational users of GHB who participated in five experimental sessions within the framework of a clinical trial. The study was randomized, double blind, double dummy and cross-over. Drug conditions were: a single oral dose of GHB (40 mg/kg or 60 mg/kg), ethanol (0.7 g/kg), flunitrazepam (1.25 mg) and placebo. Acute GHB produced a time-dependent immune impairment in the first 4 hours after drug administration associated with an increase in cortisol secretion. Although total leukocyte count remained unchanged, there was a significant decrease in the CD4 T/CD8 T-cell ratio, as well as in the percentage of mature T lymphocytes, probably because of a decrease in both the percentage and absolute number of T helper cells. A significant decrease was also observed in natural killer cells and in functional responsiveness of lymphocytes to mitogenic stimulation. Flunitrazepam administration did not produce any change in the immune system, while ethanol intake produced a decrease in B lymphocytes and in lymphocyte proliferative response to mitogens. These results provide the first evidence that GHB intake under a controlled environmental setting impairs the immunological status and confirms the alterations in the immune function caused by ethanol. [source] CLINICAL STUDY: BRIEF REPORT: Serum levels of vascular endothelial growth factor A increase during alcohol withdrawalADDICTION BIOLOGY, Issue 3 2010Annemarie Heberlein ABSTRACT Vascular endothelial growth factor A (VEGF-A) is a key regulator of angiogenesis. This study investigated VEGF-A serum levels during alcohol withdrawal (days 1, 7 and 14, 76 male patients, 38 healthy controls). Patients showed significantly higher VEGF-A serum levels (t = 2.620, P = 0.010), which increased significantly during withdrawal (F = 4.484, P = 0.014, mean difference = ,36.835, P = 0.037). The increase of VEGF-A serum levels was significantly associated with initial breath alcohol concentration and the sumscore of the severity scale of alcohol dependence (SESA questionnaire, F = 5.252, P = 0.008). Increase of VEGF-A serum levels is closely associated to alcohol intoxication and severity of alcohol dependence. [source] CLINICAL STUDY: BRIEF REPORT: Ecstasy (MDMA)-addicted subjects show increased serum levels of brain-derived neurotrophic factor, independently from a rise of drug-induced psychotic symptomsADDICTION BIOLOGY, Issue 3 2010Francesco Angelucci ABSTRACT The recreational drug ,ecstasy'[3,4-methylenedioxymethamphetamine (MDMA)] exerts a potent action on central serotonergic and dopaminergic neurons. These neurons utilize neurotrophins for their survival and function. In order to explore MDMA effects on neurotrophins, we measured by enzyme-linked immunosorbent assay the serum levels of brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) in ,ecstasy-addicted', ,ecstasy-addicted with signs of psychosis' and ,healthy' subjects. We found that BDNF serum levels were significantly increased in both groups of ,ecstasy-addicted' as compared with ,healthy subjects', supporting the hypothesis that BDNF is involved in MDMA action. [source] CLINICAL STUDY: The P300 event-related potential and its possible role as an endophenotype for studying substance use disorders: a reviewADDICTION BIOLOGY, Issue 3 2009Shubh M. Singh ABSTRACT The concept of endophenotypes has gained popularity in recent years. This is because of the potential that endophenotypes provide of measuring objective trait markers that are simpler to access and assess than complex behavioral disease phenotypes themselves. The simplicity, ease of measurement and the putative links to the etiology of the disease in the study of an endophenotype has the potential promise of unraveling the genetic basis of the disease in question. Of the various proposed endophenotypes, the P300 component of the event-related potential has been used in studies on alcoholism, schizophrenia and externalizing disorders. The current state of knowledge regarding the concept of endophenotypes, P300 and the validity of P300 as an endophenotype with special reference to substance use disorders is discussed in this review. The implications of the above are discussed. [source] CLINICAL STUDY: Alterations in pituitary-thyroid axis function among opioid-dependent subjects after acute and protracted abstinenceADDICTION BIOLOGY, Issue 3 2009Guo-fu Zhang ABSTRACT The aim of the present study was to investigate the changes in the pituitary-thyroid axis (PTA) and the time course of the hormonal alterations in subjects with opioid dependence after abstinence. Blood samples from in-patients with opioid dependence and age- and sex-matched healthy controls were collected. The severity of opioid abuse and of withdrawal symptoms was assessed. Results were compared between patients with opioid dependence (n = 30) and healthy controls (n = 30). We found that free triiodothyronine and free thyroxine levels were comparable with healthy controls while thyroid-stimulating hormone (TSH) was lower in patients in acute opioid abstinence period. Also, TSH levels in patients remained lower than controls after 30 days of abstinence. These results indicate that PTA function is altered in opioid-dependent subjects. These data highlight the importance of screening the thyroid function for individuals with chronic opioid dependence. [source] CLINICAL STUDY: A comparison of exposure to carcinogens among roll-your-own and factory-made cigarette smokersADDICTION BIOLOGY, Issue 3 2009Lion Shahab ABSTRACT Consumption of roll-your-own (RYO) tobacco is rising, but little is known about its in vivo delivery of toxins relative to factory-made (FM) cigarettes. To start to address this issue, this study compared the concentrations of metabolites of recognized human carcinogens in smokers of RYO tobacco and FM cigarettes. We opportunistically recruited 127 FM and 28 RYO cigarette smokers in central London and collected saliva and urine samples. Saliva samples were assayed for cotinine while urinary samples were assayed for 1-hydroxypyrene (1-HOP) and total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), metabolic markers of polycyclic aromatic hydrocarbons and tobacco-specific N -nitrosamines, respectively. Data on socio-demographic, anthropometric and puffing characteristics were also obtained. Both unadjusted and adjusted analyses (controlling for age, sex, body mass index, puff flow, puff duration and cotinine) showed no difference in metabolic markers between RYO and FM cigarette smokers. However, significant main effects for cotinine levels and sex were observed in adjusted analyses. Greater levels of cotinine were associated with a greater concentration of both 1-HOP (B = 0.002, P = 0.037) and NNAL (B = 0.002, P < 0.001). In addition, women had significantly greater concentrations of urinary 1-HOP (B = 0.679, P = 0.004) and total NNAL metabolites (B = 0.117, P = 0.024) than men, irrespective of the type of cigarettes smoked. More research is now needed to confirm these findings and gender-specific effects in a larger, representative sample. However, results do not support the common belief that RYO cigarettes are less harmful than manufactured cigarettes. [source] CLINICAL STUDY: Effect of saquinavir/ritonavir (1000/100 mg bid) on the pharmacokinetics of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapyADDICTION BIOLOGY, Issue 3 2009Candice Jamois ABSTRACT This study was performed to determine the effect of two protease inhibitors, saquinavir (SQV, oral 1000 mg bid) boosted by ritonavir (RTV, oral 100 mg bid), on pharmacokinetics (PK) of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapy. This was a two-center, open-label, one-sequence cross-over, multiple-dose study in 13 HIV-negative patients who were on stable methadone therapy (oral, 60,120 mg qd). All patients continued methadone treatment on days 2,15. All patients received SQV/RTV in combination with methadone from days 2,15. PK of methadone was assessed on day 1 (alone) and on day 15 when methadone treatment was combined with SQV/RTV at steady state. Twelve patients completed the study. Median age, body weight and height were 50 years (range: 24,54 years), 80 kg (range: 57,97 kg) and 174 cm (range: 163,189 cm), respectively. All patients were Caucasian, and 11 were smokers. Median methadone dose was 85 mg qd. Geometric mean area under curve of the plasma concentration-time curve over 24 hour dosing interval (AUC0,24 hour) ratio of methadone with and without SQV/RTV was 0.81% (90% confidence interval: 71,91%). There was no significant plasma protein-binding displacement of methadone by SQV/RTV. The combination of SQV/RTV and methadone was well tolerated. There were no clinically significant adverse events or significant changes in laboratory parameters, electrocardiograms or vital signs. The 19% decrease in R-methadone AUC0,24 hour in the presence of SQV/RTV was not clinically relevant. There appears to be no need for methadone dose adjustment when methadone (60,120 mg qd) and SQV/RTV (1000/100 mg bid) are coadministered. [source] CLINICAL STUDY: Predicting the effect of naltrexone and acamprosate in alcohol-dependent patients using genetic indicatorsADDICTION BIOLOGY, Issue 3 2009Wendy Ooteman ABSTRACT Acamprosate and naltrexone are effective medications in the treatment of alcoholism. However, effect sizes are modest. Pharmacogenomics may improve patient-treatment-matching and effect sizes. It is hypothesized that naltrexone exerts its effect through genetic characteristics associated with the dopaminergic/opioidergic positive reinforcement system, whereas acamprosate works through the glutamatergic/GABAergic negative reinforcement system. Alcohol-dependent subjects were randomly assigned to either acamprosate or naltrexone. Subjects participated in a cue-exposure experiment at the day before and at the last day of medication. Reductions in cue-induced craving and physiological cue reactivity were measured. Differential effects of naltrexone and acamprosate on these outcomes were tested for different polymorphisms of the opioid, dopamine, glutamate and GABA-receptors. Significant matching effects were found for polymorphisms at the DRD2, GABRA6 and GABRB2 gene. In addition, a trend was found for the OPRM1 polymorphism. This provides evidence for the matching potential of genotypes. It is expected that more effective treatments can be offered when genetic information is used in patient-treatment-matching. [source] CLINICAL STUDY: Attentional bias in alcohol-dependent patients: the role of chronicity and executive functioningADDICTION BIOLOGY, Issue 2 2009Sabine Loeber ABSTRACT It has been suggested that the attention towards alcohol-related stimuli increases with the duration of drinking and alcohol dependence. The present study aimed to assess whether an attentional bias was present in detoxified alcohol-dependent patients, and if the magnitude of the attentional bias depended on the subject's drinking history and variables of executive functioning. Attentional bias was assessed in 30 alcohol-dependent patients using a visual dot-probe task with a picture presentation time of 50 ms. In addition, patients completed a variety of different cognitive tasks such as attention, continuous performance, working memory, set shifting and inhibitory control tests. Based on correlation analysis we split the patient sample on the median with regard to the duration of alcohol dependence and our results indicated a significant attentional bias towards alcohol-associated pictures in patients dependent for less than 9 years, but not in patients with a longer duration of dependence. The two patient samples differed significantly with regard to attention and working memory functioning with patients who were dependent for more than 9 years showing a greater impairment. When impairment of attention and working memory were controlled for, the group differences in attentional bias were no longer significant. Our results indicate that differences with regard to drinking-related variables as well as cognitive functioning seem to modulate attentional bias and need to be taken into account in models of drinking maintenance. [source] CLINICAL STUDY: Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trialADDICTION BIOLOGY, Issue 2 2009Paolo Mannelli ABSTRACT Although current treatments for opioid detoxification are not always effective, medical detoxification remains a required step before long-term interventions. The use of opioid antagonist medications to improve detoxification has produced inconsistent results. Very low dose naltrexone (VLNTX) was recently found to reduce opioid tolerance and dependence in animal and clinical studies. We decided to evaluate safety and efficacy of VLNTX adjunct to methadone in reducing withdrawal during detoxification. In a multi-center, double-blind, randomized study at community treatment programs, where most detoxifications are performed, 174 opioid-dependent subjects received NTX 0.125 mg, 0.250 mg or placebo daily for 6 days, together with methadone in tapering doses. VLNTX-treated individuals reported attenuated withdrawal symptoms [F = 7.24 (2,170); P = 0.001] and reduced craving [F = 3.73 (2,107); P = 0.03]. Treatment effects were more pronounced at discharge and were not accompanied by a significantly higher retention rate. There were no group differences in use of adjuvant medications and no treatment-related adverse events. Further studies should explore the use of VLNTX, combined with full and partial opioid agonist medications, in detoxification and long-term treatment of opioid dependence. [source] CLINICAL STUDY: Proof-of-concept human laboratory study for protracted abstinence in alcohol dependence: effects of gabapentinADDICTION BIOLOGY, Issue 1 2009Barbara J. Mason ABSTRACT There is a need for safe medications that can effectively support recovery by treating symptoms of protracted abstinence that may precipitate relapse in alcoholics, e.g. craving and disturbances in sleep and mood. This proof-of-concept study reports on the effectiveness of gabapentin 1200 mg for attenuating these symptoms in a non-treatment-seeking sample of cue-reactive, alcohol-dependent individuals. Subjects were 33 paid volunteers with current Diagnostic and Statistical Manual of Mental Disorders-IV alcohol dependence and a strength of craving rating 1 SD or greater for alcohol than water cues. Subjects were randomly assigned to gabapentin or placebo for 1 week and then participated in a within-subjects trial where each was exposed to standardized sets of pleasant, neutral and unpleasant visual stimuli followed by alcohol or water cues. Gabapentin was associated with significantly greater reductions than placebo on several measures of subjective craving for alcohol as well as for affectively evoked craving. Gabapentin was also associated with significant improvement on several measures of sleep quality. Side effects were minimal, and gabapentin effects were not found to resemble any major classes of abused drugs. Results suggest that gabapentin may be effective for treating the protracted abstinence phase in alcohol dependence and that a randomized clinical trial would be an appropriate next step. The study also suggests the value of cue-reactivity studies as proof-of-concept screens for potential antirelapse drugs. [source] CLINICAL STUDY: Abnormalities in cortical and transcallosal inhibitory mechanisms in subjects at high risk for alcohol dependence: a TMS studyADDICTION BIOLOGY, Issue 3-4 2008Kesavan Muralidharan ABSTRACT Central nervous system (CNS) hyperexcitability and a resulting state of behavioral undercontrol are thought to underlie the vulnerability to early-onset alcohol dependence (AD). The aim of this study was to explore the differences in the functioning of cortical inhibitory systems, utilizing transcranial magnetic stimulation (TMS), in subjects at high risk (HR) and low risk (LR) for AD and to examine the relationship between CNS inhibition and behavioral undercontrol. Right-handed HR (n = 15) and LR (n = 15) subjects, matched for age, gender, height, weight and education, were assessed for psychopathology and family history of alcoholism using the Semi-Structured Assessment for the Genetics of Alcoholism and the Family Interview for Genetic Studies. Following single-pulse TMS, an electromyogram recorded from the right opponens pollicis muscle was used to measure the silent periods at different stimulus intensities. HR subjects had significantly shorter contralateral and ipsilateral (iSP) silent periods and a relatively higher prevalence of ,absent' iSP. They had significantly higher mean externalizing symptoms scores (ESS) than LR subjects, and there was a significant negative correlation between iSP duration and ESS. These preliminary findings suggest that HR subjects have relative impairments in corticocortical and transcallosal inhibitory mechanisms. The consequent state of CNS hyperexcitability may be etiologically linked to the excess of externalizing behaviors observed in this population, which is thought to be a predisposition to a higher risk of developing early-onset alcoholism. [source] CLINICAL STUDY: Prolactin response to fenfluramine in abstinent, alcohol-dependent patientsADDICTION BIOLOGY, Issue 3-4 2008Richard J. Porter ABSTRACT It has been suggested that serotonin (5HT) function is abnormal in alcoholics even during abstinence. The prolactin response to fenfluramine (PRF) is generally believed to reflect the activity of the 5HT system and has been previously used to investigate 5HT activity in a variety of conditions, including alcoholism. The origin of the cortisol (CORT) response to fenfluramine is less clear. The objectives of this paper are to examine the prolactin (PRL) and CORT response to dl -fenfluramine in a large cohort of males with alcohol dependence who had been abstinent for 3 weeks, and to compare this with an age-matched control group. Ninety-four subjects with a DSM-III-R diagnosis of moderate to severe alcohol dependence who had been abstinent for 3 weeks, and 23 control subjects underwent neuroendocrine challenge with dl -fenfluramine (10 mg per 10 kg body weight). PRL and CORT responses were measured. No significant difference was found in PRF between abstinent, alcoholic patients and controls (F = 2.7, d.f. = 1.115, P = 0.10). CORT response was significantly lower in abstinent alcoholics than in controls (F = 10.0, d.f. = 1.116, P = 0.002). The results suggest no clear difference in 5HT function between abstinent alcoholics and healthy controls. The reduced CORT response in abstinent alcoholics further supports evidence of hypofunction of the adrenocortical system in this group. [source] CLINICAL STUDY: Suppression of cue-induced heroin craving and cue-reactivity by single-trial transcutaneous electrical nerve stimulation at 2 HzADDICTION BIOLOGY, Issue 2 2006Fei Zhong ABSTRACT The purpose of the present study was to investigate the efficacy of 2 Hz transcutaneous electrical nerve stimulation (TENS) to reduce cue-induced heroin craving and the corresponding cardiovascular responses. Seventy heroin addicts with at least 1 month of abstinence were enrolled and randomly divided into two groups of 35, to receive single-trial 2 Hz TENS (TENS group) or mock TENS (mock group) during experimental procedure, respectively. They were required to express their degree of craving by visual analog scale before and after the presentation of a video-cue, and after TENS treatment, which lasted for 30 minutes. Heart rate and arterial blood pressure were simultaneously monitored in 56 cases, with 28 in each group. Results show that in mock group, video-cue induced a dramatic increase of craving score, which did not return to baseline in 150 minutes, whereas in the TENS group, 2 Hz TENS treatment produced a significant decrease of craving, reaching baseline in 90 minutes. Video-cue induced a significant increase of heart rate and systolic and diastolic blood pressure, which remained elevated for at least 60 minutes in the mock group; whereas in the TENS group, they returned to baseline immediately after the termination of TENS. These results indicate that the craving induced by a heroin-related cue can be immediately and significantly suppressed, and the cardiovascular activation totally abolished by a single-trial 2 Hz TENS for 30 minutes [source] TOWARD CASE-BASED REASONING FOR DIABETES MANAGEMENT: A PRELIMINARY CLINICAL STUDY AND DECISION SUPPORT SYSTEM PROTOTYPECOMPUTATIONAL INTELLIGENCE, Issue 3 2009Cindy Marling This paper presents a case-based decision support system prototype to assist patients with Type 1 diabetes on insulin pump therapy. These patients must vigilantly maintain blood glucose levels within prescribed target ranges to prevent serious disease complications, including blindness, neuropathy, and heart failure. Case-based reasoning (CBR) was selected for this domain because (a) existing guidelines for managing diabetes are general and must be tailored to individual patient needs; (b) physical and lifestyle factors combine to influence blood glucose levels; and (c) CBR has been successfully applied to the management of other long-term medical conditions. An institutional review board (IRB) approved preliminary clinical study, involving 20 patients, was conducted to assess the feasibility of providing case-based decision support for these patients. Fifty cases were compiled in a case library, situation assessment routines were encoded to detect common problems in blood glucose control, and retrieval metrics were developed to find the most relevant past cases for solving current problems. Preliminary results encourage continued research and work toward development of a practical tool for patients. [source] CLINICAL STUDY/BIOMARKER: Phosphatidylethanol: normalization during detoxification, gender aspects and correlation with other biomarkers and self-reportsADDICTION BIOLOGY, Issue 1 2010Friedrich Martin Wurst ABSTRACT Phosphatidylethanol (PEth) is a direct ethanol metabolite, and has recently attracted attention as biomarker of ethanol intake. The aims of the current study are: (1) to characterize the normalization time of PEth in larger samples than previously conducted; (2) to elucidate potential gender differences; and (3) to report the correlation of PEth with other biomarkers and self-reported alcohol consumption. Fifty-seven alcohol-dependent patients (ICD 10 F 10.25; 9 females, 48 males) entering medical detoxification at three study sites were enrolled. The study sample was comprised of 48 males and 9 females, with mean age 43.5. Mean gamma glutamyl transpeptidase (GGT) was 209.61 U/l, average mean corpuscular volume (MCV) was 97.35 fl, mean carbohydrate deficient transferrin (%CDT) was 8.68, and mean total ethanol intake in the last 7 days was 1653 g. PEth was measured in heparinized whole blood with a high-pressure liquid chromatography method, while GGT, MCV and %CDT were measured using routine methods. PEth levels at day 1 of detoxification ranged between 0.63 and 26.95 µmol/l (6.22 mean, 4.70 median, SD 4.97). There were no false negatives at day 1. Sensitivities for the other biomarkers were 40.4% for MCV, 73.1% for GGT and 69.2% for %CDT, respectively. No gender differences were found for PEth levels at any time point. Our data suggest that PEth is (1) a suitable intermediate term marker of ethanol intake in both sexes; and (2) sensitivity is extraordinary high in alcohol dependent patients. The results add further evidence to the data that suggest that PEth has potential as a candidate for a sensitive and specific biomarker, which reflects longer-lasting intake of higher amounts of alcohol and seemingly has the above mentioned certain advantages over traditional biomarkers. [source] Comparison of a Long-Pulse Nd:YAG Laser and a Combined 585/1,064-nm Laser for the Treatment of Acne Scars: A Randomized Split-Face Clinical StudyDERMATOLOGIC SURGERY, Issue 11 2009SEONG UK MIN MD BACKGROUND Nonablative laser is gaining popularity because of the low risk of complications, especially in patients with darker skin. OBJECTIVE To compare the efficacy and safety of a long-pulse neodymium-doped yttrium aluminium garnet (Nd:YAG) laser and a combined 585/1,064-nm laser for the treatment of acne scars. MATERIALS AND METHODS Nineteen patients with mild to moderate atrophic acne scars received four long-pulse Nd:YAG laser or combined 585/1,064-nm laser treatment sessions at fortnightly intervals. Treatments were administered randomly in a split-face manner. RESULTS Acne scars showed mild to moderate improvement, with significant Echelle d'évaluation clinique des cicatrices d'acné (ECCA) score reductions, after both treatments. Although intermodality differences were not significant, combined 585/1,064-nm laser was more effective for deep boxcar scars. In patients with combined 585/1,064-nm laser-treated sides that improved more than long-pulse Nd:YAG laser-treated sides, ECCA scores were significantly lower for combined 585/1,064-nm laser treatment. Histologic evaluations revealed significantly greater collagen deposition, although there was no significant difference between the two modalities. Patient satisfaction scores concurred with physicians' evaluations. CONCLUSION Both lasers ameliorated acne scarring with minimal downtime. In light of this finding, optimal outcomes might be achieved when laser treatment types are chosen after considering individual scar type and response. [source] Role of Intralesional Bleomycin in the Treatment of Complicated Hemangiomas: Prospective Clinical StudyDERMATOLOGIC SURGERY, Issue 5 2005Shapour Omidvari MD background. Hemangioma is the most common tumor of infancy. Although it has a basically benign nature and usually spontaneously regresses, a small percentage (5%) have complications that need treatment. Many different therapeutic modalities can be used in this tumor. objective. To investigate the effect of a new method of treatment (intralesional bleomycin injection) in complicated hemangiomas. materials and methods. In the Department of Radiation Oncology at Nemazee Hospital in Shiraz, Iran, from April 1992 to October 1998, 32 patients with complicated hemangioma were treated with four to six courses of direct injection of bleomycin into the lesion. results After a minimum follow-up of 6 years, there was 70 to 100% regression in 18 patients, 50 to 70% in 7 cases, and less than 50% reduction in 7 patients. conclusion. Intralesional injection of bleomycin is an easy, safe, and effective therapeutic modality in complicated cutaneous hemangiomas. [source] Nonablative 1450-nm Diode Laser in the Treatment of Facial Atrophic Acne Scars in Type IV to V Asian Skin: A Prospective Clinical StudyDERMATOLOGIC SURGERY, Issue 10 2004Sze-Hon Chua MRCP (UK) Background. There is presently little published data on the clinical effectiveness of nonablative lasers in the treatment of atrophic acne scars and the safety of their use in patients with darker skin types. Objective. This study aims to determine the clinical effectiveness and safety of the nonablative 1450 nm diode laser with cryogen cooling spray in the treatment of facial atrophic acne scars in Type IV-V Asian skin. Methods. This is a prospective non-comparative open study. 4 to 6 laser treatment sessions were performed on patients with atrophic acne scars. Final clinical assessment was performed 6 months after the last treatment. Results. 57 patients were evaluated. Patient's self-assessment of scar improvement as compared with doctor's assessment was as follows: patients who completed 4 treatments (15.7% vs 6.6%), patients who completed 5 treatments (20% vs 7.9%) and patients those who completed 6 treatments (17.3% vs 5.0%). Main side effects were mild to moderate pain during the procedure, transient erythema, and hyperpigmentation which occurred in 39% of treated patients. Conclusion. The nonablative 1450 nm diode laser may be effective in achieving mild to moderate gradual clinical improvement in the treatment of facial atrophic acne scars. The procedure is associated with minimal downtime and is safe for use in darker skin types IV and V. [source] Digital Analysis of Myocardial Contrast Echocardiography: A Clinical Study Using an Air-Filled Agent in Normal SubjectsECHOCARDIOGRAPHY, Issue 3 2000EDWARD A. GEISER M.D., F.A.C.C. The purpose of the present study was to determine whether direct digital image analysis would allow improved detection of myocardial contrast. Eighteen normal subjects were recruited and separated into two groups. In group 1, the time-brightness curves of the left ventricular cavity and three myocardial perfusion beds were formed from digitized video tape, with output power and imaging time as secondary variables. In group 2, curves constructed from direct polar digital data were compared, with fundamental and second harmonic image formation as variables. In group 1 subjects, using fundamental imaging, the area under the curve in the left ventricular cavity increased slightly with intermittent imaging. No consistent myocardial opacification was identified. In group 2 subjects, using intermittent imaging, the area under the myocardial curve and peak intensity increased with high output second harmonic imaging in the left anterior descending and right coronary artery regions. Intermittent, second harmonic imaging and digital processing can demonstrate myocardial contrast even with an air-filled agent. [source] A Multicenter, Randomized Clinical Study to Evaluate the Effect on Cognitive Function of Topiramate Compared with Valproate as Add-On Therapy to Carbamazepine in Patients with Partial-Onset SeizuresEPILEPSIA, Issue 9 2000A. P. Aldenkamp Summary: Purpose: This study compares the cognitive effects of topiramate (TPM) with those of valproate (VPA) using efficacious doses of each drug when used as adjunctive therapy to carbamazepine (CBZ). A key question of the study is to what extent a more gradual introduction of TPM improves tolerabil-ity and prevents cognitive impairment. Methods: The study is a multicenter, randomized, observer-blinded, parallel-group clinical trial with VPA or TPM given as first-line add-on therapy to steady-state treatment with CBZ. TPM is introduced at 25 mg and increased with weekly 25-mg/d increments to a minimum dosage of 200 mg/d. The target dosage ranges from 200 to 400 mg/d for TPM and is 1800 mg/d for VPA. The study evaluates cognitive function changes from baseline to end point (after 20 weeks of treatment) and during titration (after 8 weeks of treatment). The primary outcome measure is the difference between the treatments (TPM versus VPA) in change from baseline to end point and change from baseline to titration, using a 95% confidence interval approach. Results: For the 10 baseline-to-end point comparisons, one test measuring short-term verbal memory (Rey Auditory Verbal Learning Test) yields a statistically significant difference between the treatments (p = 0.02), showing worsening for TPM and improvement of scores for VPA. The 10 baseline-to-titration comparisons also show one statistically significant difference, again for a test measuring short-term memory (Recognition of Words; p = 0.04), showing a larger change in the negative direction for TPM. None of the mood tests or the test for subjective complaints shows statistically significant differences between the treatments, although more scores are in the negative direction for TPM during titration. Conclusion: Although the pattern of changes in the negative direction seems consistent with clinical information, the differences found between the treatments are small. An important finding of our study is that, when the results are compared with those of other studies, it is clear that gradual introduction of TPM can reduce the extent of cognitive impairment (with a maximum of about 0.6 SD). [source] A Clinical Study of Migraine EvolutionHEADACHE, Issue 8 2007Leslie Kelman MD No abstract is available for this article. [source] A Clinical Study of Migraine EvolutionHEADACHE, Issue 8 2007William Pryse-Phillips MD No abstract is available for this article. [source] Computer Imaging versus Conventional Esthetic Consultation: A Prospective Clinical StudyJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 2 2000OLGA S. PAPASOTIRIOU DMD ABSTRACT Computer imaging can be helpful in demonstrating to patients the potential outcome of esthetic dental procedures. The current clinical study assesses the effectiveness of computer imaging by comparing the reactions of patient and dentist to conventional consultations versus the use of computer imaging. The responses from 35 subjects show that computer imaging consultations are more effective in helping patients decide to accept treatment. Patient satisfaction was higher (93.75%) with computer consultations than with conventional methods (83.3%). Computer imaging consultations were easier to conduct but significantly (p < .05) more time consuming. CLINICAL SIGNIFICANCE This experiment confirms the role of computer imaging as an effective aid in esthetic dentistry consultations and treatment planning. Imaging facilitates communication between patient and practitioner and provides a more realistic view of anticipated treatment outcomes. [source] Prevalence of Noncarious Cervical Lesions and Their Relation to Occlusal Aspects: A Clinical StudyJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 1 2000DANIEL TELLES DDS ABSTRACT Purpose: The purpose of this study was to assess noncarious cervical lesions in young patients and to establish a possible relation with occlusal aspects. Materials and Methods: Forty-eight dental students (28 males; 20 females) between the ages of 16 and 24 years, were investigated to verify the presence of noncarious cervical lesions and their relation to some occlusal aspects. The assessment involved a questionnaire, clinical examinations, and model analysis. Results: The results indicated that the lower first molars (21.3%), the upper first molars (16.0%), the upper first premolars (12.8%), the lower first premolars (11.7%), and the lower second premolars (11.7%) were the teeth most affected by the lesions. Age was a significant factor with respect to the presence of lesions; the students with noncarious cervical lesions were older than the students who showed no lesions. Among the 79 teeth exhibiting lesions, 62 (78.5%) showed wear facets. In the group with lesions, the mean, per subject, was 15.0 teeth with wear facets, whereas in the group without lesions the mean was 10.8 teeth with wear facets per subject, suggesting that occlusal stress has some effect on lesion development. CLINICAL SIGNIFICANCE Noncarious cervical lesions are characterized by loss of tooth structure on the cervical area of the tooth and can result in esthetic problems for the patient, as well as discomfort due to the hyper-sensibility that often occurs at the location of the lesion. The results obtained reinforce the multifactorial theory, shared by several authors, for the etiology of such lesions. However, as the limitations of each etiologic agent begin to be understood, there will be a decrease in the possibility of misleading interpretations of the result of present or future investigations. [source] Interesting Findings in an Initial Clinical Study of Neuropeptides and PainPAIN MEDICINE, Issue 10 2010Robert L. Ruff MD No abstract is available for this article. [source] Efficacy and Safety of On-Demand Oral Tadalafil in the Treatment of Men with Erectile Dysfunction in Taiwan: A Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical StudyTHE JOURNAL OF SEXUAL MEDICINE, Issue 2 2004Kuang-Kuo Chen MD Conflict of Interest. Timothy M. Costigan and Jeffrey T. Emmick are employees of Eli Lilly, Indianapolis. ABSTRACT Introduction., Tadalafil is a phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (ED). Past clinical trials have assessed its efficacy and safety in western populations. Tadalafil has not been investigated in a large clinical trial with a South-east Asian population. Aim., To assess the efficacy and safety of on-demand tadalafil for the treatment of ED in a 12-week, double-blind, placebo-controlled study in Taiwan. Methods., Men with mild to severe ED of various etiologies were randomized to receive placebo, tadalafil 10 mg, or tadalafil 20 mg, taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). Results., Tadalafil significantly improved erectile function compared with placebo (P < 0.005, all measures). At endpoint, the patients receiving tadalafil reported a greater mean per-patient percentage of successful intercourse attempts (SEP question 3: 70.0%, 10 mg; 78.0%, 20 mg) than placebo-treated patients (42.8%) and a greater proportion of improved erections (GAQ: 92.3% and 84.6% vs. 54.5%). Most treatment-emergent adverse events were mild or moderate. The most common adverse events were back pain, dyspepsia, and myalgia. Conclusions., Tadalafil was an effective, well-tolerated therapy for men in Taiwan with ED of broad-spectrum severity and etiology. [source] Albumin-Coated Tympanostomy Tubes: Prospective, Double-Blind Clinical Study,THE LARYNGOSCOPE, Issue 11 2004Teemu J. Kinnari MD Abstract Objectives: Coating an implant with albumin prevents adhesion of proteins, bacteria, and platelets and thus may lead to its improved and prolonged function. Previously, we have demonstrated the inhibition of binding of fibronectin, one of the most adhesive glycoproteins, on human serum albumin (HSA)-coated tympanostomy tubes and the durability of this binding inhibition in a 8-month trial. We have also demonstrated that the HSA coating inhibits the binding of Staphylococcus aureus and Pseudomonas aeruginosa to titanium plates. This prospective study evaluated the effect of albumin coating on tympanostomy tube sequelae and on the outcome of tympanostomized patients. Study Design: Double-blind, prospective, randomized clinical trial. Methods: Two otolaryngological centers in southern Finland enrolled 179 pediatric patients. Number of tube occlusions and otorrhea and tube ventilation time in the ears with HSA-coated titanium tympanostomy tubes were compared with the contralateral ear with its uncoated, otherwise identical titanium tube during a 9-month follow-up period. Results: In HSA-coated tubes, average ventilation time was slightly longer and the number of early tube occlusions significantly less (P < .05). Moreover, in patients with perioperative bleeding, the coating prolonged average ventilation time of tympanostomy tubes significantly (P < .05). Conclusions: HSA coating reduces early tube occlusions by preventing adherence of blood and secretion. [source] Optimal Bayesian Design for Patient Selection in a Clinical StudyBIOMETRICS, Issue 3 2009Manuela Buzoianu Summary Bayesian experimental design for a clinical trial involves specifying a utility function that models the purpose of the trial, in this case the selection of patients for a diagnostic test. The best sample of patients is selected by maximizing expected utility. This optimization task poses difficulties due to a high-dimensional discrete design space and, also, to an expected utility formula of high complexity. A simulation-based optimal design method is feasible in this case. In addition, two deterministic algorithms that perform a systematic search over the design space are developed to address the computational issues. [source] Turned Brånemark System® Implants in Wide and Narrow Edentulous Maxillae: A Retrospective Clinical StudyCLINICAL IMPLANT DENTISTRY AND RELATED RESEARCH, Issue 2 2008Bertil Friberg DDS ABSTRACT Background: The available jawbone volume is regarded as one of the most important factors when assessing the prognosis of oral implants in the rehabilitation of the edentulous maxilla. Purpose: The aim of the current investigation was to retrospectively evaluate and compare the outcome of implants placed in edentulous maxillae with either wide or narrow jaw shapes. The marginal bone loss and implant cumulative survival rates (CSRs) were calculated and analyzed with special reference to smoking habits. Materials and Methods: The study included 75 individuals with edentulous maxillae, of which 33 patients exhibited wide (group A) and 42 patients exhibited narrow jaw shapes (group B). A total of 506 turned Brånemark System® (Nobel Biocare AB, Göteborg, Sweden) implants were inserted (226 in group A and 279 in group B) and followed clinically up to 7 years. Smoking habits were recorded. Radiographs were obtained at connection of prostheses, and at the 1- and 5-year follow-up visit. The marginal bone loss was calculated for the groups and analyzed using t -test. Results: Twenty-eight implants were lost during the study period, revealing implant CSRs at 7 years of 94.6% (11/226) and 93.6% (17/279) for wide and narrow crests, respectively. No difference in marginal bone loss was seen between the two groups, although a trend toward more bone loss was recorded for patients with wide crests. Smoking habits were more common in group A (45%) than in group B (31%). During the first year of function, smokers lost significantly more marginal bone than nonsmokers (p = .0447), albeit this difference did not prevail (p > .05) at the end of the study period. Conclusions: The implant CSRs at 7 years were equally good for the two groups of patients with various jaw shapes. Initially, smokers showed significantly more marginal bone loss than nonsmokers. [source] | |||||||||||||||||||||||||||||||||||||||||||