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Open Study (open + study)
Kinds of Open Study Selected AbstractsAN OPEN STUDY OF RILUZOLE VERSUS RILUZOLE PLUS GABAPENTIN IN AMYOTROPHIC LATERAL SCLEROSISJOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 1 2000V Palma A randomised open study has been carried out to evaluate the efficacy of riluzole versus riluzole plus gabapentin in 50 patients (23 males, 27 females) affected by amyotrophic lateral sclerosis (ALS), who received the diagnosis according to El Escorial WFN criteria. At baseline, the mean age of the patients was 58.8 ± 11.7 years and the mean disease duration was 11.4 ± 5.9 months. Twenty patients had bulbar and 30 spinal onset. Twenty-eight patients were randomly assigned to riluzole (100 mg/day) and 22 to riluzole plus gabapentin at the initial dose of 300 mg/day, slowly increased to 1800 mg/day. Informed consent was obtained in all cases. Before treatment, each patient underwent neurological examination, Appel rate scale, pulmonary function tests, electromyography, and transcranial magnetic stimulation. Clinical examination and electrophysiologic tests were repeated at three-month intervals. Over the course of the trial, 4 patients (8%) were lost to follow-up and 16 (32%, 9 in the riluzole and 7 in the riluzole plus gabapentin group) died. The mean age at death was 65.0 ± 6.5 years after a mean disease duration of 20.8 ± 7.9 months (range 13,36). There was no significant difference in response to treatment when severity and duration of the disease were compared in the two groups. [source] Recombinant hGH replacement therapy and the hypothalamus,pituitary,thyroid axis in children with GH deficiency: when should we be concerned about the occurrence of central hypothyroidism?CLINICAL ENDOCRINOLOGY, Issue 6 2003Claudia Giavoli Summary objective, Recombinant hGH treatment may alter thyroid hormone metabolism and we have recently reported that 50% of patients with GH deficiency (GHD) due to organic lesions, previously not treated with thyroxine, developed hypothyroidism during treatment with recombinant human GH (rhGH). These results prompted us to evaluate the impact of rhGH treatment on thyroid function in children with GHD. design, Open study of GH treatment up to 12 months. Investigations were performed at baseline, and after 6 and 12 months of GH therapy. measurement and study subjects, Serum TSH, FT4, FT3, AbTg and AbTPO, IGF-I, height and weight, were evaluated in 20 euthyroid children (group A) with idiopathic isolated GHD and in six children (group B) with multiple pituitary hormone deficiencies (MPHD) due to organic lesions. Among the latter, four already had central hypothyroidism and were on adequate LT4 replacement therapy, while two were euthyroid at the beginning of the study. results, Serum IGF-I levels normalized in all patients. In both groups, a significant reduction in FT4 levels (P < 0·01) occurred during rhGH therapy. No patient in group A had FT4 values into the hypothyroid range, while in four of six patients in group B, fell FT4 levels into the hypothyroid range during rhGH. In particular, the two euthyroid children developed central hypothyroidism during rhGH treatment, and their height velocities did not normalize until the achievement of euthyroidism through appropriate LT4 substitution. No variation in serum FT3 and TSH levels was recorded in either groups. conclusion, Contrary to that observed in patients with MPHD, rhGH replacement therapy does not induce central hypothyroidism in children with idiopathic isolated GHD, further supporting the view that in children with MPHD, as in adults, GHD masks the presence of central hypothyroidism. Slow growth (in spite of adequate rhGH substitution and normal IGF-I levels) is an important clinical marker of central hypothyroidism, therefore a strict monitoring of thyroid function is mandatory in treated children with MPHD. [source] Catheter-Assisted Vein Sclerotherapy: A New Approach for Sclerotherapy of the Greater Saphenous Vein with a Double-Lumen Balloon CatheterDERMATOLOGIC SURGERY, Issue 4 2007JENS P. BRODERSEN MD OBJECTIVE We sought to optimize sclerotherapy of the greater saphenous vein (GSV) by targeted application of foamed sclerosant by using a catheter. METHODS We designed a new double-lumen catheter that is inserted into the GSV. Via one lumen, a balloon at the tip of the catheter can be inflated to stop the blood flow. Via the second lumen, the sclerosing agent can be injected and aspirated. This method enabled us to perform a targeted application of the sclerosing agent [catheter-assisted vein sclerotherapy (KAVS)]. In an open study, outpatients suffering from varicosis of the GSV received a foam sclerotherapy under ultrasound guidance, using the newly developed KAVS catheter. RESULTS Thirty patients with an insufficiency (reflux) of the GSV were treated with the newly developed KAVS method using foamed polidocanol. The intervention was well tolerated in all patients without the occurrence of serious side effects. In 27 of the 30 treated patients (90%), we found a closure of the GSV at control visits 6 weeks, 3 months, and 6 months after treatment. CONCLUSIONS The KAVS method represents a feasible approach for sclerotherapy of the GSV. The efficiency and treatment modalities need to be explored in further studies. [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] Clinical Improvement of Solar Lentigines and Ephelides with an Intense Pulsed Light SourceDERMATOLOGIC SURGERY, Issue 6 2002Akira Kawada MD background. A noncoherent, broadband, intense pulsed light (IPL) source has been used for the symptoms of photoaging skin as a nonablative method. objective. To investigate the efficacy and tolerability of IPL in solar lentigines and ephelides on the face. methods. An open study was performed in patients with solar lentigines and ephelides who received three to five treatments of IPL. results. Forty-eight percent of patients had more than 50% improvement and 20% had more than 75% improvement. In the group of solar lentigines, 40% of patients showed more than 50% improvement and 16% had more than 75% improvement. Patients with small plaques of solar lentigines responded well, whereas patients with small + large and large plaques showed poor response. Patients with solar lentigines + ephelides and ephelides responded remarkably with 75% and 71% of patients, respectively, having more than 50% improvement. conclusion. IPL was well tolerated and may be a new modality for the therapy of solar lentigines and ephelides. [source] Effect of pantoprazole in patients with chronic laryngitis and pharyngitis related to gastroesophageal reflux disease: clinical, proximal, and distal pH monitoring resultsDISEASES OF THE ESOPHAGUS, Issue 4 2010S. Karoui SUMMARY Few studies had evaluated the results of proton pump inhibitors on distal and proximal pH recording using a dual-channel probe. The aim of this study was to determine the clinical and pH-metric effect of treatment with pantoprazole 80 mg for 8 weeks in patients with ear, nose, and throat (ENT) manifestations of gastroesophageal reflux disease associated with pathological proximal acid exposure. We conducted a prospective open study. Patients included had to have chronic pharyngitis or laryngitis, and a pathological gastroesophagopharyngeal reflux. All patients received treatment with pantoprazole 80 mg daily for 8 weeks. One week after the end treatment, patients had a second ENT examination and a 24-hour pH monitoring using dual-channel probe. We included 33 patients (11 men, 22 women). A pathological distal acid reflux was found in 30 patients (91%). After treatment, the improvement of ENT symptoms was found in 51.5% of patients. Normalization of 24-hour proximal esophageal pH monitoring was observed in 22 patients (66%). After treatment, the overall distal acid exposure, the number of distal reflux events, and the number of reflux during more than 5 minutes were significantly decreased (respectively: 19.4% vs 7.2% [P < 0.0001], 62.7 vs 28.4 [P < 0.0001], and 10.4 vs 3.9 [P < 0.0001] ). Similarly, in proximal level, the same parameters were significantly decreased after treatment (respectively: 6.8% vs 1.6% [P < 0.0001], 32.6 vs 8.1 [P < 0.0001], and 3.4 vs 0.6 [P= 0.005] ). Treatment with pantoprazole reduced the frequency and severity of gastroesophagopharyngeal acid reflux in patients with chronic pharyngitis and laryngitis. [source] Nicotine as an Antiepileptic Agent in ADNFLE: An N-of-One StudyEPILEPSIA, Issue 9 2003John O. Willoughby Summary:,Purpose: To test nicotine patch treatment for a patient with a defined mutation for autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE) whose seizures were refractory to standard antiepileptic therapy. Methods: Open and double-blind trials of nicotine patches in an "n-of-one" study. The double-blind trial comprised periods during which either placebo or nicotine patches were each used for three periods of 2 weeks, randomized in a double-blind manner. Results: In an open study, nicotine patches reduced seizures from 1.65 ± 2.36 to 0.01 ± 0.0 seizures per day (p < 0.0001). In a double-blinded placebo-controlled phase, the average frequency of seizures on nicotine versus placebo was 0 ± 0 versus 0.56 ± 1.14 seizures per day (p < 0.0001). Conclusions: Nicotine patches may be of benefit to some individuals with ADNFLE. [source] Aesculus hippocastanum for the treatment of chronic venous insufficiency , an open studyFOCUS ON ALTERNATIVE AND COMPLEMENTARY THERAPIES AN EVIDENCE-BASED APPROACH, Issue 1 2003S Dickson [source] Executive function assessment of patients with schizophrenic disorder residual type in olanzapine treatment: an open studyHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2005Paolo Stratta Abstract Cognitive deficits are a fundamental feature of the schizophrenic disorder, but the effect of antipsychotic treatment is still debated. The study assesses the effect of olanzapine on neurocognitive functioning and symptomatology of patients with schizophrenic disorder residual type. Executive function evaluation by the Wisconsin card sorting test (WCST) was performed on 39 patients treated with olanzapine (5,20,mg/day); the efficacy of drug in improving symptomatology, safety and quality of life was also evaluated. After 7 months of treatment, the mean number of WCST categories tended to increase. Correct responses increased with a statistically significant change from the baseline. The total and unique errors decreased significantly. At all post-baseline visits a decrease from baseline in the PANSS total, positive and negative scores was seen. The proportion of patients with less severe illness (CGI), increased over the course of the study with a corresponding decrease of patients with more severe illness. The quality of life scores also tended to improve during treatment. The Simpson Angus scale, Barnes-akathisia and abnormal involuntary movement scale scores decreased consistently. The most common treatment emergent drug related adverse events were weight gain, insomnia, agitation and anxiety. Neurocognitive functioning in terms of executive performance and symptomatology improved in people with schizophrenia residual type. Copyright © 2005 John Wiley & Sons, Ltd. [source] An open study of risperidone liquid in the acute phase of schizophreniaHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 4 2005Reiji Yoshimura Abstract An open-label study was performed to investigate the clinical efficacy and mechanisms of risperidone liquid in ameliorating positive symptoms in the acute phase of schizophrenia. Eighty-eight patients (M/F: 50/38; age: 18,74 years;, mean±SD =32±16 years) meeting DSM-IV criteria for schizophrenia and treated with risperidone liquid (14 patients also used lorazepam) were evaluated with regard to their clinical improvement and extrapyramidal side effects using the positive and negative syndrome scale (PANSS) and the Simpson and Angus scale (SAS), while plasma concentrations of HVA and MHPG were analysed by HPLC-ECD before and 4 weeks after risperidone liquid administration. Patients showing a 50% or greater improvement in PANSS scores were defined as responders. An improvement in the PANSS scores related to excitement, hostility and poor impulse control was seen within 7 days after administration of risperidone liquid, and an improvement with regard to hallucinatory behaviour and uncooperativeness was seen within 14 days after its administration. Finally, 68% of patients were classified as responders 4 weeks after risperidone liquid administration. The scores of SAS were not changed after risperidone liquid administration. Pretreatment plasma homovanillic acid (HVA) levels in the responders (8.1±2.9,ng/ml) were higher than those in nonresponders (5.9±1.9,ng/ml). In addition, a negative correlation was seen between the changes in plasma HVA levels and the percentage of improvement in PANSS scores. On the other hand, there were no differences between pretreatment plasma 3-methoxy-4-hydroxyphenylglycol (MHPG) levels and those of nonresponders. These results suggest that risperidone liquid is effective and well tolerated for the treatment of acute phase schizophrenic patients, and that efficacy is related to its affects on dopaminergic activity, not noradrenergic activity. Copyright © 2005 John Wiley & Sons, Ltd. [source] Measurement of antipsychotic-induced side effects: Support for the validity of a self-report (LUNSERS) versus structured interview (UKU) approach to measurementHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2003T. J. R. Lambert Abstract A self-report measure of antipsychotic side effects (LUNSERS) was compared with that of an established semi-structured interview (UKU side effect rating scale). The validity and the ability of the LUNSERS to determine false positives by use of an internal ,red herring' subscale were assessed. ,Red herring' items are those which do not directly relate to known antipsychotic side effects. In an open study, 29 patients with schizophrenia and schizoaffective disorder from inpatient and outpatient settings within an Australian metropolitan mental health service were assessed for antipsychotic-induced side effects using both the LUNSERS and UKU. The LUNSERS and UKU were similar in their overall assessment of antipsychotic side effects (total score correlation of 0.58) and were correlated on a wide array of individual side effect items. Correlations between total scores and individual items were higher for those patients scoring low on the LUNSERS ,red herring' items compared with both those with high ,red herring' scores and the sample as a whole. Several LUNSERS items were identified as potentially problematic, requiring further explanation or supplementation with direct questioning. The ,red herring' scale appears to enable detection of patients that may be over-reporting symptomatology. The LUNSERS is a valuable self-report measure of antipsychotic side effects, particularly in cases where red herring scores are low. Copyright © 2003 John Wiley & Sons, Ltd. [source] Antidepressant efficacy and cognitive effects of repetitive transcranial magnetic stimulation in vascular depression: an open trialINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 9 2004I. Fabre Abstract Background Beneficial effects of repetitive transcranial magnetic stimulation (rTMS) were demonstrated by many controlled studies in major depression. Moreover, this promising and non invasive therapeutic tool seems to be better tolerated than electroconvulsive therapy. Vascular depression is a subtype of late-life depression, associated with cerebrovascular disease and means a poorer response to antidepressant treatment. We employed rTMS over the left prefrontal cortex in 11 patients with late-onset resistant vascular depression. The primary purpose of this two-week open study was to examine antidepressant efficacy of rTMS in vascular depression. The secondary aim was to evaluate cognitive effects of rTMS in our sample. Methods Clinical status, as measured with the Hamilton Depression Rating Scale (HDRS), and cognitive effects, as evaluated by neuropsychological tests, were assessed at baseline and after two weeks of rTMS. Brain measurements to obtain an index of prefrontal atrophy were performed at both the motor cortex and prefrontal cortex. Results Five out of 11 resistant patients with late-onset vascular depression were responders. They showed a clinically meaningful improvement in HDRS scores, with a decrease of 11, 4 points (p<0.01). Antidepressant response is correlated to the relative degree of prefrontal atrophy (p = 0.05). After two weeks, verbal fluency and visuospatial memory improved. No cognitive performance deteriorated except for verbal memory, as the delayed recall decreased significantly in the responders' group. Conclusions Our preliminary observations prompt to perform a subsequent controlled study to examine if rTMS may constitute an alternative to electroconvulsive therapy. Copyright © 2004 John Wiley & Sons, Ltd. [source] New and innovative therapies for Behcet's diseaseINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 2 2004Fereydoun DAVATCHI Abstract Background:, Behcet's disease (BD) is a vasculitis progressing by attacks and remissions. Not all patients will respond even to the classical treatments. New treatments are emerging with the hope to overcome this failure. Biologic agents:, Interferon-, (IFN-,), anti-tumour necrosis factor-, (TNF-,), and tolerization have been used in BD. IFN-, is mainly used for ocular manifestations of BD. The result seems impressive, 92% of cases had good or excellent results. It was less impressive for mucocutaneous and joint manifestations. The dosage is 6,9 million IU/day for 4 weeks, then 4.5 million daily for 4 weeks, and then 3 million/day. The maintenance dose is 3 millions, three times/week, to continue for 8 weeks after complete remission. Etanercept (anti-TNF-,) was effective in mucocutaneous lesions of BD at the dosage of 25 mg twice weekly for 3 months (double-blind control study). Attacks relapsed after discontinuation. Etanercept was ineffective in ocular lesions (open study). Infliximab (anti-TNF-,) was very effective in many studies of ocular lesions. It dramatically suppressed the inflammatory attack. The dosage is one injection of 5 mg/kg (intravenous infusion) at weeks 0, 2, 6, and then every 8 weeks. Tolerization with oral administration of HSP peptide 336,351 seems to protect from uveitis relapse. Pentoxifylline is not particularly effective unless for oral aphthae (50% response rate). Pimecrolimus ointment may be of help in resistant genital aphthosis, reducing the healing time. [source] Synchronised therapy and high-dose cyclophosphamide in proliferative lupus nephritisJOURNAL OF CLINICAL APHERESIS, Issue 2 2002Maria Giovanna Danieli Abstract The aim of this open study was to compare the outcomes and side effects of plasmapheresis (PP) in patients with proliferative lupus nephritis treated with cyclophosphamide (Cyc) boluses. The study involved 28 consecutive patients. All of the patients met the ACR modified criteria for SLE and underwent a qualifying renal biopsy. In group I, patients were treated with synchronised therapy (PP, 50 ml/kg, followed by pulse Cyc, 750 mg/m2, repeated monthly for 6 months), whereas in group II, they were given only intermittent Cyc boluses (at the same dosage). The data were collected in the patients' records according to a standardised protocol. Patients were followed-up for a mean of 4 years. The disease-free survival was analysed using Kaplan-Meier estimated survival curves ([S(t)]). At the end of the 6-month treatment period, a statistically significant number of patients in group I (75%) was in complete remission in comparison to group II (31%) (P < 0.02), whereas at long-term follow-up, these percentages were similar (41% vs. 50%, P = n.s.). The main functional and immunological parameters showed a normalisation in both groups. The risk of a poor renal outcome significantly correlated with high serum creatinine levels at the onset of nephritis (P < 0.05). We documented a higher rate of infectious complications in group I. This study reports that synchronised therapy is useful in inducing a faster remission in patients with proliferative lupus nephritis. However, it is not superior to conventional therapy at long term follow-up analysis. Positive results should be reinforced by a long-term maintenance therapy. J. Clin. Apheresis 17:72,77, 2002. © 2002 Wiley-Liss, Inc. [source] AN OPEN STUDY OF RILUZOLE VERSUS RILUZOLE PLUS GABAPENTIN IN AMYOTROPHIC LATERAL SCLEROSISJOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 1 2000V Palma A randomised open study has been carried out to evaluate the efficacy of riluzole versus riluzole plus gabapentin in 50 patients (23 males, 27 females) affected by amyotrophic lateral sclerosis (ALS), who received the diagnosis according to El Escorial WFN criteria. At baseline, the mean age of the patients was 58.8 ± 11.7 years and the mean disease duration was 11.4 ± 5.9 months. Twenty patients had bulbar and 30 spinal onset. Twenty-eight patients were randomly assigned to riluzole (100 mg/day) and 22 to riluzole plus gabapentin at the initial dose of 300 mg/day, slowly increased to 1800 mg/day. Informed consent was obtained in all cases. Before treatment, each patient underwent neurological examination, Appel rate scale, pulmonary function tests, electromyography, and transcranial magnetic stimulation. Clinical examination and electrophysiologic tests were repeated at three-month intervals. Over the course of the trial, 4 patients (8%) were lost to follow-up and 16 (32%, 9 in the riluzole and 7 in the riluzole plus gabapentin group) died. The mean age at death was 65.0 ± 6.5 years after a mean disease duration of 20.8 ± 7.9 months (range 13,36). There was no significant difference in response to treatment when severity and duration of the disease were compared in the two groups. [source] An open study of antibiotics for the treatment of pre-pouch ileitis following restorative proctocolectomy with ileal pouch,anal anastomosisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2009S. D. MCLAUGHLIN Summary Background, Pre-pouch ileitis is a recently described condition which may occur following restorative proctocolectomy. Its aetiology remains unknown and only one study has reported the effect of treatment. We report a series of fourteen patients treated and followed up with repeat pouchoscopy. Aim, To study the effectiveness of antibiotics for the treatment of pre-pouch ileitis following restorative proctocolectomy with ileal pouch,anal anastomosis. Methods, Fourteen consecutive patients with symptomatic pre-pouch ileitis were treated with ciprofloxacin 500 mg b.d. and metronidazole 400 mg b.d. for 28 days. All had concurrent pouchitis. Symptomatic, endoscopic and histological assessment was performed before and following treatment using the pouchitis disease activity index (PDAI). Symptomatic remission was defined as a score of 0 in the clinical component of the PDAI. Results, Twelve (86%) patients experienced symptomatic remission. Stool frequency fell from a median of 12 (range 8,20) to 6 (4,17) (P = 0.002). There was a significant reduction in the anatomical length of pre-pouch ileitis with nine (64%) patients having either a resolution or a reduction in length of pre-pouch ileitis from a median of 10 cm (range 3,20 cm) to a median of 1 cm (range 0,10 cm) (P = 0.007). Conclusion, Combination antibiotic therapy in this uncontrolled study appears effective in reducing the length of pre-pouch ileitis and in inducing symptomatic remission in most patients whether or not its extent is reduced. [source] Oral, colonic-release low-molecular-weight heparin: an initial open study of Parnaparin-MMX for the treatment of mild-to-moderate left-sided ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2008L. PASTORELLI Summary Background, Efficacy of heparin and low-molecular-weight heparins (LMWHs) in inflammatory bowel disease (IBD) treatment has been suggested. The multimatrix oral formulation MMX releases active drugs in the colon, avoiding systemic absorption. Parnaparin sodium is the LMWH chosen to be carried in the MMX formulation. Aim, To assess the safety of three different oral dosages (70, 140 and 210 mg once daily) of Parnaparin-MMX (CB-01-05) in left-sided ulcerative colitis (UC). Methods, Left-sided UC patients, with a mild-to-moderate relapse were enrolled. All patients received Parnaparin-MMX for 8 weeks. Clinical Activity Index (CAI), Disease Activity Index (DAI), Endoscopic Activity Index and IBD-QoL were assessed throughout the study. A strict clinical and laboratory follow-up, including assessment of anti-factor Xa activity, was performed. Clinical remission was defined as CAI <4. Results, Ten UC patients were enrolled. One patient retired for clinical deterioration. No relevant side effects, including either interference with haemostasis parameters or increased bleeding, were observed. At the end of the treatment, seven patients (70%) were in clinical remission, only one achieving endoscopic healing. Mean final CAI, DAI and IBD-QoL scores were significantly improved from baseline. Conclusions, Parnaparin-MMX appears to be a safe treatment option in mild-to-moderate UC. Controlled studies are warranted. [source] Therapeutic efficacy of bilateral prefrontal slow repetitive transcranial magnetic stimulation in depressed patients with Parkinson's disease: An open studyMOVEMENT DISORDERS, Issue 3 2002a Draga, evic MD Abstract Recent studies have suggested that both high- and low-frequency repetitive transcranial magnetic stimulation (rTMS) have antidepressant effects in patients with major depression. We conducted an open study to assess the effects of slow rTMS on mood changes in patients with depression associated with Parkinson's disease (PD). Ten depressed patients with PD (four with major depression and six with dysthymia) received daily sessions of rTMS (frequency, 0.5 Hz; pulse duration, 0.1 msec; field intensity, 10% above the motor threshold) over both prefrontal regions (a total of 100 stimuli per prefrontal region daily) over 10 consecutive days. This treatment resulted in a moderate but significant decrease in scores of the Hamilton Depression Rating Scale (33,37%) and the Beck Depression Inventory (24,34%), which persisted 20 days after finishing the stimulation. In parallel, we observed mild improvement (18,20%) of motor symptoms. No significant adverse effects were reported. These preliminary results suggest the therapeutic potential of daily prefrontal low-frequency rTMS (0.5 Hz) in depression associated with PD. © 2002 Movement Disorder Society [source] Bispectral index, predicted and measured drug levels of target-controlled infusions of remifentanil and propofol during laparoscopic cholecystectomy and emergenceACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 9 2000S. C. Høymork Background: Target-controlled infusions (TCI) have been launched as simple, accurate and reliable delivery systems of intravenous drugs. Bispectral index of EEG (BIS) seems promising in measuring hypnotic effect of anaesthetic drugs. The aims of this study were to evaluate the accuracy of TCI systems in patients undergoing laparoscopic cholecystectomy and to correlate measured drug levels to BIS values. Data were analysed for possible gender differences during emergence. Methods: After written informed consent, 20 patients were enrolled in an open study. Remifentanil was set at 7.5 ng/ml as target throughout the whole procedure, and propofol at 5 ,g/ml at induction and 3 ,g/ml after intubation. Values in blood samples of remifentanil and propofol were correlated to the estimated values and to systolic blood pressure and BIS. BIS values and measured drug levels during emergence and emergence time were compared for the two sexes. Results: Measured drug values varied considerably from the set target with a prediction error of ,22% for remifentanil and 49% for propofol. The anaesthesia level was regarded as quite deep with a mean BIS during stable surgery of 42±7, and at this level we found no correlation between measured values of either of the two drugs and BIS. The emergence time was significantly shorter for women (12.6±2.5 min) than for men (19.0±4.2 min) (P=0.001), with no significant differences in measured levels of propofol or remifentanil or BIS during the emergence period. Conclusion: Present systems for TCI of remifentanil and propofol result in large intra- and interindividual variations in measured drug levels, and measured levels differ from target. There may be possible interaction between the two anaesthetics at a pharmacokinetic level. Within the level of anaesthesia studied here, BIS was not an indicator of the actual drug levels. Women woke up significantly faster than men. [source] MULTIDISCIPLINARY PAIN ABSTRACTS: 12PAIN PRACTICE, Issue 1 2004Article first published online: 15 MAR 200 The purpose of this study was to investigate whether selective nerve fiber dysfunction, as assessed by quantitative sensory testing (QST), correlates with the effectiveness of epidural steroid injections (ESI) in patients with lumbar radiculopathy. Twenty patients with unilateral painful sciatica caused by disc herniation participated in this open study. Before ESI, quantitative thermal and mechanical sensory testing was conducted at the most painful dermatome and the contralateral dermatome. The primary outcome measure used was the self-recording of pain intensity twice daily with a 0,10 numerical pain scale (NPS). Secondary efficacy measures included the Short Form of the McGill Pain Questionnaire, the straight leg raising test, and the lumbar range of motion. A significant difference in all types of sensory thresholds between the affected and the contralateral dermatomes was detected at baseline. All outcome measures improved subsequent to the ESI. A significant positive correlation was found between the increase in cold sensation thresholds of the affected dermatome (Adelta-fiber dysfunction) and the improvement in NPS. The increase in touch and vibration thresholds (Abeta-fiber dysfunction) was found to be inversely correlated with the improvement in NPS. No correlation was found between heat sensation thresholds and any of the outcome measures. These results suggest that QST has the potential to be an important tool in the selection of the appropriate treatment for patients with sciatica and may assist in identifying the mechanisms of pain generation in these patients. [source] Clinical effect of low-energy double-pass 1450 nm laser treatment for acne in AsiansPHOTODERMATOLOGY, PHOTOIMMUNOLOGY & PHOTOMEDICINE, Issue 1 2009Reiko Noborio Background: While the 1450 nm diode laser is highly effective for the treatment of acne, its use is associated with considerable pain. Low-energy, double-pass irradiation was attempted as an alternative to prevent the occurrence of pain as an adverse effect. Purpose: This study aimed to evaluate the clinical efficacy of low-energy, double-pass, 1450 nm diode laser treatment in the treatment of acne in Asian patients. Methods: Thirty Japanese patients with inflammatory acne were treated with the low-energy, double-pass, 1450 nm diode laser at 2,4-week intervals. An open study was performed in patients that underwent at least five and up to 10 treatment sessions. The clinical effect was assessed using an acne grading scale. Results: Of the 30 patients, 27 completed the study. The mean acne grades decreased from 3.9 to 1.4 (P<0.01) in the 27 patients. The pain was tolerated by 25 patients, and two patients required local anesthesia. No remarkable side effects occurred in any of the patients; all but a few patients had transient faint erythema. Conclusion: Low-energy, double-pass therapy is an alternative method that is beneficial for patients who complain of considerable pain. Furthermore, the method may have a lower risk of transient hyperpigmentation induced by cryogen spray, even in Asian patients who tend to develop inflammatory pigmentation. [source] Food supplementation with an olive (Olea europaea L.) leaf extract reduces blood pressure in borderline hypertensive monozygotic twinsPHYTOTHERAPY RESEARCH, Issue 9 2008Tania Perrinjaquet-Moccetti Abstract Hypertension is a harmful disease factor that develops unnoticed over time. The treatment of hypertension is aimed at an early diagnosis followed by adequate lifestyle changes rather than pharmacological treatment. The olive leaf extract EFLA®943, having antihypertensive actions in rats, was tested as a food supplement in an open study including 40 borderline hypertensive monozygotic twins. Twins of each pair were assigned to different groups receiving 500 or 1000 mg/day EFLA®943 for 8 weeks, or advice on a favourable lifestyle. Body weight, heart rate, blood pressure, glucose and lipids were measured fortnightly. Blood pressure changed significantly within pairs, depending on the dose, with mean systolic differences of ,6 mmHg (500 mg vs control) and ,13 mmHg (1000 vs 500 mg), and diastolic differences of ,5 mmHg. After 8 weeks, mean blood pressure remained unchanged from baseline in controls (systolic/diastolic: 133 ± 5/77 ± 6 vs 135 ± 11/80 ± 7 mmHg) and the low-dose group (136 ± 7/77 ± 7 vs 133 ± 10/76 ± 7), but had significantly decreased for the high dose group (137 ± 10/80 ± 10 vs 126 ± 9/76 ± 6). Cholesterol levels decreased for all treatments with significant dose-dependent within-pair differences for LDL-cholesterol. None of the other parameters showed significant changes or consistent trends. Concluding, the study confirmed the antihypertensive and cholesterol-lowering action of EFLA®943 in humans. Copyright © 2008 John Wiley & Sons, Ltd. [source] Transcranial magnetic stimulation for the deficit syndrome of schizophrenia: A pilot investigationPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 3 2005PERMINDER SACHDEV md, franzcp Abstract, In an open study, four subjects with a stable deficit syndrome of schizophrenia received high frequency repetitive transcranial magnetic stimulation (15 Hz at 90% of motor threshold, 1800 pulses each session, daily for 20 sessions over 4 weeks) over the left dorsolateral prefrontal cortex. Subjects showed a significant reduction in negative symptoms and improvement in function, with no change in positive symptoms. This improvement was maintained at the 1 month follow up. Repetitive transcranial magnetic stimulation as a treatment of the deficit syndrome of schizophrenia is feasible, safe and may be beneficial. A systematic study in randomized control trials would be appropriate. [source] Evaluation of anti-wrinkle effects of a novel cosmetic containing retinol using the guideline of the Japan Cosmetic Industry AssociationTHE JOURNAL OF DERMATOLOGY, Issue 11 2009Akira KAWADA Abstract Retinol is known to be effective in the treatment of sallowness, wrinkling, red blotchiness and hyperpigmented spots in aging skin. In this study, we have evaluated the anti-wrinkle effects of a new cosmetic containing retinol. An open study was performed in 30 healthy Japanese women who had wrinkles at the corners of the eyes. The tested lotion, Retin-OX+ (RoC SA, Colombes, France), was applied on wrinkles of one side of the face for 8 weeks, and not on the other site as a control. Anti-wrinkle effects were evaluated by two methods: (i) doctors' observation and photos based on the guideline of the Japan Cosmetic Industry Association; and (ii) the Robo Skin Analyzer. This lotion showed marked and moderate improvement in 34% of the subjects with a significant difference as compared with the control sites (P < 0.05). Moreover, the length and area decreased in the applied site more than the control site with a significant difference (P < 0.01). All the patients completed the study without significant adverse reactions. The tested lotion was well tolerated and may be an optional preparation for the treatment of wrinkles at the corner of the eyes. [source] Clinical benefit of joint distraction in the treatment of severe osteoarthritis of the ankle: Proof of concept in an open prospective study and in a randomized controlled studyARTHRITIS & RHEUMATISM, Issue 11 2002Anne C. A. Marijnissen Objective Osteoarthritis (OA) is a degenerative, disabling joint disease that affects >10% of the adult population. No effective disease-modifying treatment is available. In the present study, we used joint distraction, a relatively new treatment in which mechanical contact between the articular surfaces is avoided while intraarticular intermittent fluid pressure is maintained, to treat patients with severe OA of the ankle. Methods Patients with severe ankle OA (n = 57) who were being considered for joint fusion (arthrodesis) were treated with joint distraction in an open prospective study. In addition, a randomized trial was performed in 17 patients to determine whether joint distraction had a better outcome than debridement. A standardized evaluation protocol (physical examination, assessment of pain, mobility, and functional ability) was used, and changes in radiographic joint space width and subchondral sclerosis were measured. Thirty-eight patients in the open study have been followed up for >1 year, with up to 5 years of followup in 7 of them (mean ± SD followup 2.8 ± 0.3 years). Patients in the randomized study have been followed up for 1 year. Results Significant clinical benefit was found in three-fourths of the 57 patients in the open prospective study. Most interestingly, the improvement increased over time. Radiographic evaluation showed increased joint space width and decreased subchondral sclerosis. Moreover, joint distraction showed significantly better results than debridement. Conclusion The clinical benefit of joint distraction in the treatment of severe OA is proof of the concept. Although the followup remains relatively short and effects over time remain unpredictable, our study creates possibilities for the treatment of severe OA in general. Considering the high prevalence of OA and the lack of a cure for it, joint distraction as a treatment of severe OA may have great medical, social, and economic impact. [source] An open study of B lymphocyte depletion in systemic lupus erythematosusARTHRITIS & RHEUMATISM, Issue 10 2002Maria J. Leandro Objective To gain preliminary evidence for the safety and efficacy of B lymphocyte depletion therapy in refractory systemic lupus erythematosus (SLE). Methods Six female patients with active SLE, resistant to standard immunosuppressive therapy, were treated on an open-label basis. During a 2-week period, each patient received two 500-mg infusions of rituximab, two 750-mg infusions of cyclophosphamide, and high-dose oral corticosteroids. Results No significant adverse events were observed during followup. Patient 1 had not improved at 3 months but was then lost to followup. At 6 months, all 5 remaining patients had improved, as evidenced by improvement in British Isles Lupus Assessment Group global scores, from a median of 14 (range 9,27) at baseline to a median of 6 (range 3,8) at 6 months. Manifestations of SLE such as fatigue, arthralgia/arthritis, and serositis responded particularly well to this protocol. Hemoglobulin levels increased in patients 2, 3, 5, and 6. The erythrocyte sedimentation rate decreased in patients 2, 3, 4, and 5 and was stable in patient 1. In patients 4 and 5, the urinary protein,to-creatinine ratio decreased significantly. C3 serum levels increased in all 5 patients who had low levels at baseline; in two of these patients, patients 2 and 5, C3 values were normal at 6 months. The variation in the level of anti,double-stranded DNA antibody was different in individual patients. Conclusion This study provides sufficient evidence for the safety and possible efficacy of B lymphocyte depletion therapy in SLE to justify a formal controlled trial. [source] Posterior tibial nerve stimulation in patients with intractable interstitial cystitisBJU INTERNATIONAL, Issue 1 2004Jimao Zhao OBJECTIVE To evaluate the efficacy of intermittent percutaneous posterior tibial nerve stimulation (PPTNS) in patients with refractory interstitial cystitis. PATIENTS AND METHODS One man and 13 women (mean age 58.3 years) with suprapubic or perineal pain were enrolled in a prospective open study, in which they had 10 weekly sessions of PPTNS. Their mean duration of symptoms was 8.3 years. All patients were previously diagnosed as having interstitial cystitis according to the National Institute of Diabetes and Digestive and Kidney Diseases criteria. The response to the treatment were assessed using voiding diary, visual analogue scale diary for a pain index, and the Interstitial Cystitis Problem Index (ICPI), O'Leary/Sant Interstitial Cystitis Symptom Index (ICSI) and the 36-item short-form health survey (SF-36) quality-of-life questionnaire. RESULTS Of the 14 patients, 13 completed the 10 weeks of treatment with no complications; 12 continued treatment for a short period after the study. There were no statistically significant changes in pain scores, voiding frequency and volumes, or in the ICPI, ICSI and SF-36 scores. However, there was an improvement in some patients, with one having complete resolution of the pain. CONCLUSION Intermittent PPTNS in patients with refractory interstitial cystitis has no significant clinical effect over 10 weeks of treatment. [source] Fine-needle aspiration biopsy with ultrasound guidance in patients with malignant melanoma and palpable lymph nodesBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2006S. Dalle Summary Background, Recurrence after treatment of stage I,II melanoma involves regional lymph nodes in about 50% of patients. A reliable method is needed to evaluate lymph node status (metastatic or not) in the case of palpable lymph nodes. Objectives, To evaluate the efficiency of fine-needle aspiration biopsy (FNAB) in examining clinically detected suspicious lymph node in patients followed up after surgical removal of stage I,II melanoma. Patients and methods, One hundred and twenty FNABs were performed in 67 patients with a suspicious node in an open study conducted in a French melanoma regional referral centre, Hôpital de l'Hôtel-Dieu. Cytodiagnosis was classified as positive, negative, inadequate or inconclusive. Sensitivity, specificity, positive and negative predictive values and positive and negative likelihood ratios were calculated after final histopathological evaluation. Results, Fifty-eight of 120 FNABs were positive (48%), 50 of 120 (42%) were negative, four of 120 (3%) were inconclusive and eight of 120 (7%) were inadequate. Among the 108 FNABs in which a definitive diagnosis could be given, sensitivity was 98·2% [95% confidence interval (CI) 90·7,99·9] and specificity was 96·1% (95% CI 86·8,98·9). Conclusions, FNAB under ultrasound guidance is an efficient tool to discriminate better between cases in which surgical treatment of the lymph node basin should be performed and patients who should return for follow-up. Surgical treatment appears to be required in cases of positive FNAB or in inconclusive cases. [source] Azelaic acid as a new treatment for perioral dermatitis: results from an open studyBRITISH JOURNAL OF DERMATOLOGY, Issue 4 2004T. Jansen No abstract is available for this article. [source] Pulsed dye laser treatment of telangiectasia after radiotherapy for carcinoma of the breastBRITISH JOURNAL OF DERMATOLOGY, Issue 1 2003S.W. Lanigan Summary Background Chronic radiodermatitis after radiotherapy for carcinoma of the breast is a common sequela of treatment and can be distressing for the patient. The skin is atrophic and shows prominent telangiectasia due to dilatation of a reduced or poorly supported skin vasculature. The pulsed dye laser (PDL) is an established treatment of cutaneous telangiectatic disorders including facial telangiectasia and spider naevi, and is safe and efficacious. Objectives To study the efficacy of the PDL in the treatment of postradiation telangiectasia of the breast or chest wall. Methods Prospective open study of the treatment of eight females with the Candela SPTL1B PDL. Subjective assessments of vessel clearance, adverse effects and patient questionnaires. Results All treated patients showed complete clearance of vessels. Two patients developed hypopigmentation. All patients reported a high degree of satisfaction with the treatment. Conclusions PDL therapy clears postirradiation telangiectasia of the breast and chest wall successfully with minimal adverse reactions, and can be recommended for patients distressed by this disorder. [source] | |||||||||||||||||||||||||||||||