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Label Study (label + study)

Distribution by Scientific Domains
Medical Sciences100%
Distribution within Medical Sciences
Neurology30%

Kinds of Label Study

  • open label study
    		•

    Selected Abstracts

    Is Eradication of Helicobacter pylori With Colloidal Bismuth Subcitrate Quadruple Therapy Safe?

    HELICOBACTER, Issue 2 2001
    Rosemary H. Phillips
    ABSTRACT Background. When standard triple therapy fails to eradicate Helicobacter pylori, quadruple ,rescue' therapy is often used which, in Europe, generally comprises colloidal bismuth subcitrate (CBS) based triple therapy and a proton pump inhibitor. Since hypochlorhydria could greatly increase absorption of the toxic bismuth ion from CBS, we investigated the bismuth status of patients receiving anti- H. pylori quadruple therapy. Materials and Methods. In a prospective open label study 34 patients with nonulcer dyspepsia or peptic ulcer disease, who had failed to eradicate H. pylori with standard triple therapy, were subsequently treated with CBS, omeprazole, amoxycillin and metronidazole (BOAM). A further 35 patients received triple therapy for the eradication of H. pylori: CBS, amoxycillin and metronidazole (BAM) (n = 18); placebo bismuth, amoxycillin and metronidazole (AM) (n = 9); or omeprazole, amoxycillin and metronidazole (OAM) (n = 8). Whole blood bismuth levels were determined before and within 24 hours of completing treatment. Analysis of bismuth was by inductively coupled plasma mass spectrometry, and concentrations were compared between groups and with the Hillemand ,alarm level' for blood bismuth (50,100 µg/l). Results. BOAM gave higher blood bismuth levels than BAM (difference in means 13.1, CI 6.0,20.2, p < .001); three (8.8%) patients taking BOAM had concentrations within the Hillemand alarm level at 54.2, 64.7 and 91.8 µg/l. OAM and AM did not alter baseline blood bismuth levels. Conclusions. Caution should be observed in prescribing CBS with gastric acid suppression, and alternative bismuth preparations should be considered. [source]

    The efficacy of reboxetine in the treatment-refractory patients with panic disorder: an open label study

    HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 7 2002
    P. N. Dannon
    Abstract Background and Objective Selective serotonin reuptake inhibitors (SSRIs) are currently the first-line treatment for panic disorder, although up to 30% of patients either do not respond to SSRIs or withdraw due to adverse events. Reboxetine, a selective norepinephrine reuptake inhibitor (selective NRI), is effective in treating depression and may alleviate depression-related anxiety. This study aimed to investigate the efficacy of reboxetine in the treatment of patients with panic disorder who did not respond to SSRIs. Method In this 6-week, open-label study, 29 adult outpatients with panic disorder who had previously failed to respond to SSRI treatment received reboxetine 2,mg/day, titrated to a maximum of 8,mg/day over the first 10 days. Efficacy was assessed using the Panic Self-Questionnaire (PSQ), the Hamilton Rating Scale for Anxiety (HAM-A), the 17-item Hamilton Rating Scale for Depression (HRSD) and the Global Assessment of Functioning (GAF) Scale. Results The 24 patients who completed the study responded well to reboxetine treatment. Significant improvement (p,<,0.001) was observed in the number of daily panic attacks, and on the scales measuring anxiety, depression and functioning. Reboxetine was generally well tolerated. Five patients withdrew due to adverse events. Conclusions Reboxetine appears to be effective in the treatment of SSRI-refractory panic disorder patients and warrants further clinical investigation. Copyright © 2002 John Wiley & Sons, Ltd. [source]

    Long term safety and efficacy of donepezil in the treatment of dementia in Alzheimer's disease in adults with Down syndrome: open label study

    INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 6 2003
    V. P. Prasher
    No abstract is available for this article. [source]

    Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: Results of a randomized, double-blind, vehicle-controlled study

    JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 11 2006
    Markus Dawid
    Pimecrolimus; Elidel®; Vitiligo Summary Background: Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult to treat. In an earlier open label study in adult patients with vitiligo, pimecrolimus cream 1% was reported to have similar efficacy as clobetasol propionate 0.05%. We performed a double-blind, intrapatient comparison of pimecrolimus cream 1% with placebo cream. Patients and methods: Twenty adult Caucasians with symmetrical vitiligo (predominantly on extremities, none in the face) were treated b.i.d. for 6 months left/right with pimecrolimus/vehicle (N = 10) or vehicle/pimecrolimus (N = 10), respectively. Primary efficacy endpoint was the size of the target lesion at month 6 and secondary efficacy endpoint was re-pigmentation. Results: Treatment with pimecrolimus cream 1% or vehicle resulted in no significant change in mean target lesion size. Modest repigmentation (1,25%) was noted with pimecrolimus at month 2 in 12 of 17 patients (vehicle: 9 of 17 patients). Afterwards, the number of patients who experienced an improvement of pigmentation steadily decreased (3 of 14 patients with pimecrolimus and 2 of 14 with placebo at month 6).Treatment was well tolerated. There were no treatment-related adverse events, no induction of skin atrophy nor any other application site side effects. Conclusion: In this group of adult patients with symmetrical vitiligo, treatment of body lesions (except face) with pimecrolimus cream 1% could not be shown to be effective. Zusammenfassung Hintergrund: Vitiligo ist eine erworbene Pigmentstörung der Haut, die entstellend und schwer zu behandeln ist. In einer früheren offenen Studie an erwachsenen Patienten mit Vitiligo wurde mit Pimecrolimus-Creme 1% eine ähnliche Wirksamkeit beobachtet wie mit Clobetasol propionat 0.05%. Bei der vorliegenden Studie handelte es sich um einen doppelblinden, intraindividuellen Vergleich von Pimecrolimus-Creme 1% und Plazebo-Creme. Patienten und Methodik: Zwanzig erwachsene Patienten weißer Hautfarbe mit symmetrischer Vitiligo (vorwiegend an den Extremitäten) wurden zweimal täglich über 6 Monate im Halbseitenvergleich mit Pimecrolimus/Cremegrundlage (N = 10) oder Cremegrundlage/Pimecrolimus (N = 10) behandelt. Primärer Endpunkt war die Größe der behandelten Läsion, sekundärer Endpunkt der Prozentsatz an Repigmentierung. Ergebnisse: Die Behandlung mit Pimecrolimus-Creme 1% oder Vehikel ergab keine signifikante ,nderung der durchschnittlichen Größe der Läsion. Eine mäßige (1,25%) Repigmentierung wurde mit Pimecrolimus bei 12 von 17 (Grundlage:9 von 17) Patienten in Monat 2 beobachtet. Anschließend nahm die Anzahl der Patienten, die eine Repigmentierung aufwiesen, kontinuierlich ab (3 von 14 unter Pimecrolimus, 2 von 14 unter Grundlage im Monat 6). Die Behand-lung wurde gut vertragen. Es gab keine behandlungsbedingten Zwischenfälle und keine Induktion von Hautatrophie oder irgendwelche anderen Nebenwirkungen an der Applikationsstelle. Schlussfolgerung: In dieser Gruppe erwachsener Patienten mit symmetrischer Vitiligo konnte eine Wirksamkeit der Behandlung von Läsionen am Körper (nicht Gesicht) mit Pimecrolimus-Creme nicht gezeigt werden. [source]

    Acetyl-l-carnitine in the treatment of painful antiretroviral toxic neuropathy in human immunodeficiency virus patients: an open label study

    JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 1 2006
    Maurizio Osio
    Abstract Antiretroviral toxic neuropathy causes morbidity in human immunodeficiency virus (HIV) patients under dideoxynucleoside therapy, benefits only partially from medical therapy, and often leads to drug discontinuation. Proposed pathogeneses include a disorder of mitochondrial oxidative metabolism, eventually related to a reduction of mitochondrial DNA content, and interference with nerve growth factor activity. Carnitine is a substrate of energy production reactions in mitochondria and is involved in many anabolic reactions. Acetyl carnitine treatment promotes peripheral nerve regeneration and has neuroprotective properties and a direct analgesic role related to glutamatergic and cholinergic modulation. The aim of this study was to evaluate acetyl-l-carnitine in the treatment of painful antiretroviral toxic neuropathy in HIV patients. Twenty subjects affected by painful antiretroviral toxic neuropathy were treated with oral acetyl-l-carnitine at a dose of 2,000 mg/day for a 4-week period. Efficacy was evaluated by means of the modified Short Form McGill Pain Questionnaire with each item rated on an 11-point intensity scale at weekly intervals and by electromyography at baseline and final visit. Mean pain intensity score was significantly reduced during the study, changing from 7.35 ± 1.98 (mean ± SD) at baseline to 5.80 ± 2.63 at week 4 (p = 0.0001). Electrophysiological parameters did not significantly change between baseline and week 4. In this study, acetyl-l-carnitine was effective and well tolerated in symptomatic treatment of painful neuropathy associated with antiretroviral toxicity. On the contrary, no effect was noted on neurophysiological parameters. [source]

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

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

    Open label study of the effect of amantadine on weight gain induced by olanzapine

    PSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 2 2004
    WON-MYONG BAHK md
    Abstract, The purpose of the present paper was to investigate the effects of the dopamine agonist amantadine in those patients with weight gain induced by olanzapine. An open trial was conducted in those patients who gained >3 kg in weight induced by olanzapine use. All subjects were evaluated by weight, body mass index (BMI), the Brief Psychiatric Rating Scale (BPRS), and the Extrapyramidal Symptom Rating Scale (ESRS) before and after the use of amantadine in addition to olanzapine. Twenty-five of 30 enrolled patients completed the present study. Mean bodyweight and BMI was increased by 6.44 ± 4.42 kg and 5.04 ± 3.47 kg/m2 significantly with olanzapine alone (P < 0.001). When amantadine and olanzapine were used together, the average weight and BMI decreased by 1.07 ± 3.19 kg and 0.84 ± 2.5 kg/m2, but did not have statistical significance. The average values of BPRS showed a significant decrease (P < 0.001). No significant changes were present in ESRS. Amantadine did not have an effect on weight gain induced by olanzapine. Randomized placebo-controlled prospective studies are needed. [source]

    The use of Butea superba (Roxb.) compared to sildenafil for treating erectile dysfunction

    BJU INTERNATIONAL, Issue 2 2010
    Jeff R. Cortés-González
    Study Type , Therapy (case control) Level of Evidence 3b OBJECTIVE To evaluate the effect of an extract of Butea superba (Roxb.) (BS) compared to sildenafil for treating erectile dysfunction (ED). PATIENTS AND METHODS An open label study was carried out among 32 men with organic ED to evaluate the response on the International Index of Erectile Function 5 (IIEF-5) to BS, a ,natural health' product (100 mg), compared to 50 mg of sildenafil (a phosphodiesterase-5 inhibitor). After a 1-week wash-out, responders to BS received either 100 mg starch or 100 mg of another batch of BS (double-blind). RESULTS Of the patients in the BS group, 27 (84%) responded positively, compared with 26 (81%) in the sildenafil group. When assessing the score alone, 12 (38%) had a better score after taking BS, compared to seven (22%) after sildenafil, and eight (25%) had the same score. The results were surprising and could not be repeated in the double-blind part of the study, where no effect of BS was recorded. CONCLUSIONS A ,natural' health product containing BS was more effective than sildenafil in the first part of the study, but in the second, using another batch of BS, the positive result could not be repeated and no effect was recorded. The conclusion is that the first preparation of BS was most likely blended with a phosphodiesterase-5 inhibitor, later confirmed by the supplier of BS (a natural health products company) after their own analysis. [source]

    Effects of rivastigmine on the quantitative EEG in demented Parkinsonian patients

    ACTA NEUROLOGICA SCANDINAVICA, Issue 4 2003
    N. Fogelson
    Objectives, , Quantitative electroencephalogram (qEEG) can be used to measure the effects of drugs on the brain. We studied the effects of rivastigmine on the qEEG in Parkinson's disease (PD) patients with dementia. Subjects and methods, , Demented PD patients (n=19) were treated with rivastigmine in an open label study. Recordings were obtained prior to and following 12 weeks of treatment. Results were analyzed using two-way ANOVA with repeated measures. Results, , A significant increase in the relative alpha (P < 0.05) activity was observed after treatment with rivastigmine. This was general rather than localized to specific brain surface areas. An increase in beta activity and decrease in the slower frequencies (delta and theta) were also observed; however, these were not statistically significant. Conclusion, , qEEG may serve as an objective tool to monitor the effects of antidementia drug therapy. The changes characterized by increased faster frequencies and decreased slower frequencies that were observed may indicate increased arousal or improvement in the cognitive state of the patients as a consequence of the treatment with rivastigmine. [source]

    2327: Preservative free tafluprost 0.0015% in the treatment of patients with ocular hypertension and glaucoma: results of a multi-center open-label observational study

    ACTA OPHTHALMOLOGICA, Issue 2010
    I LANZL
    Purpose Efficacy, tolerability and safety of the novel preservative-free prostaglandin tafluprost 0.0015% were investigated. Methods Data were collected in a non-interventional prospective multi-center observational open label study. IOP readings were recorded for each eye at baseline (prior therapy or untreated) and 12 weeks after changing or initiating treatment with preservative-free tafluprost. Change in IOP was evaluated over the study period for all patients and for specific pre-treatment subgroups. Local comfort was measured using a 5 step scale. All adverse events were recorded. Results Data from 2123 patients with glaucoma or ocular hypertension were eligible for the final evaluation. In all patients preservative-free tafluprost lowered IOP from 19.5+4.4 mmHg at baseline to 16.4+2.9 mmHg after 12 weeks. Preservative-free tafluprost also lowered IOP significantly in all monotherapy-subgroups: Na,ve patients (N=440): 22.6+3.9 mmHg to 16.7+2.7mmHg; betablockers (N=307): 20.3+3.5 mmHg (baseline) to 16.7+2.6 mmHg (week 12); CAI's (N=158): 19.0+3.6 mmHg to 16.0+2.6 mmHg; PG's (N=447): 16.8+2.9 mmHg to 15.8+2.6 mmHg. Local comfort was rated as 'very good' or 'good' by 85.6% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion Preservative-free tafluprost was effective, well tolerated and safe in a broad patient population. Local comfort and patient satisfaction improved after change of medical treatment in the vast majority of patients. Commercial interest [source]