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NCT ID: NCT01855802 Completed - Glaucoma Clinical Trials

Greek Physicians Perceptions Regarding Generics Prescribing in Glaucoma

Start date: April 2013
Phase: N/A
Study type: Observational

This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics prescription in glaucoma by means of a structured questionnaire.

NCT ID: NCT01855659 Completed - Pulmonary Disease Clinical Trials

A Single-center Study to Assess Peak Inspiratory Flow (PIF) in Different Stages' COPD Patients by Using the In-check Method.

INSPIRE
Start date: June 2013
Phase: N/A
Study type: Observational

Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the inspiratory cycle. Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are available for the administration of inhaled corticosteroids, as well as bronchodilators, with each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®, Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with a consequent airflow across the DPI. This inspiratory flow has to be high enough to disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory flows (PIFs) are not only dependent on a patient's inhalation effort but also on the internal resistance of the device. It has been shown that optimal deposition of medication with DPIs is not achieved in some patients with low inspiratory flow rates, such as children or patients with COPD, especially during acute exacerbations. In such conditions the use of a DPI with low internal resistance has been suggested, ensuring an optimal deposition despite the lower flow rate. In addition, many clinicians are nowadays confronted with an important number of COPD patients who are aged >70 yrs

NCT ID: NCT01853826 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Start date: July 17, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

NCT ID: NCT01853462 Completed - Ankle Sprains Clinical Trials

Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains

Start date: December 2014
Phase: N/A
Study type: Interventional

The purpose of this study was to determine the effects of supervised balance and proprioceptive neuromuscular facilitation (PNF) training for the rehabilitation of ankle sprains

NCT ID: NCT01853254 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

Start date: September 2003
Phase: Phase 3
Study type: Interventional

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

NCT ID: NCT01852578 Completed - NSCLC Clinical Trials

Cabazitaxel in Relapsed and Metastatic NSCLC

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The investigators propose to study the single agent activity of Cabazitaxel in a Phase II trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with docetaxel, given the fact of its significant activity and its acceptable toxicity profile.

NCT ID: NCT01851824 Completed - Clinical trials for Malignant Melanoma, Neoplasms

A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 [NCT01739764]).

NCT ID: NCT01849406 Completed - Snoring Clinical Trials

Effect of Nasal Steroids in Snoring Intensity

Start date: April 2013
Phase: Phase 1
Study type: Interventional

It is anecdotally well known that patients snore more when their nose is blocked. However, the therapeutic effect of improving nasal airway patency on snoring indices remains a point of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed to show any improvement in the number of snores after its application, although apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that dilation of the anterior nares in patients without nasal pathology has a relatively weak effect on snoring, and routine use of nasal dilating appliances was not recommended for the treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea (OSA) implying that there might be an equivalent result for the use of nasal steroids on snoring indices. Additionally, the present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively have decreased nasal breathing epochs. It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal steroids might also increase nasal breathing epochs and lead to decreased snoring indices in patients who had decreased nasal breathing before the administration of nasal steroids. Patients will be randomized in two groups: the patients of the first group will undergo a one week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week of nasal normal saline. The patients of the second group will undergo a one week therapy of nasal normal saline, then two weeks of washout period, and thereafter one week of nasal budesonide. Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern. The investigators hypothesize that the application for one week of nasal budesonide has a beneficial effect on snoring indices in patients who present before the application decreased proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing nasal breathing epochs.

NCT ID: NCT01847521 Completed - Clinical trials for Autism Spectrum Disorders

Effects of the Anti-inflammatory Flavonoid Luteolin on Behavior in Children With Autism Spectrum Disorders

Start date: December 2011
Phase: Phase 2
Study type: Interventional

Background. Increasing evidence indicates that brain inflammation is important in the pathogenesis of neuropsychiatric disorders, including at least a significant proportion of subjects with Autism spectrum disorder (ASD). Natural flavonoids, such as luteolin and quercetin, exhibit potent antioxidant and anti-inflammatory activities, inhibit the release of inflammatory mediators from human mast cells, and reduce maternal interleukin 6-induced autism-like behavioral deficits related to social interactions in mice. In a case series of 37 children with ASD who took a dietary supplement containing luteolin and quercetin for 4 months reported gains in eye contact, attention and social interaction according to parental reports. Aim. The purpose of this study was to assess the effectiveness and tolerability in white children with ASD of a dietary supplement containing 2 flavonoids, luteolin and quercetin, and the quercetin glycoside rutin. Methods. Fifty children (42 boys and 8 girls) divided into 2 equal age groups (4-6 years old, and 7-10 years) with ASD were enrolled in a 26-week, prospective, open-label trial at the 2nd University Department of Psychiatry at "Attikon" General Hospital, Athens, Greece, the Ethics Committee of which approved the study. The parents of all subjects were informed of the study's aims, including risks versus benefits of participating and not participating as well as the inclusion and exclusion criteria, and they written consent for participation in the study. Participants had already been diagnosed with ASD based on clinical assessments, and this diagnosis was corroborated at the 'Attikon' clinic by meeting the cutoff scores on both the DSM-IV-TR, symptom list and the ADOS algorithm. All children were medication naive. Apart from the diagnostic evaluation, the assessment also included a thorough medical evaluation comprising a physical examination and health history (including a review of allergic and gastrointestinal symptoms, as well as any food allergies or food intolerance). All concurrent interventions were thoroughly noted (type and hours), and the same was done at all visits. After meeting screening criteria, subjects were evaluated at the baseline visit, mid-trial visit at 18 weeks, and final visit at 26 weeks. Children were administered a dietary formulation containing 2 flavonoids, luteolin (100 mg/capsule) and quercetin (70 mg/capsule), and the quercetin glycoside rutin (30 mg/capsule). The dose used was 1 softgel capsule per 10 kg (22 lb) weight per day with food for 26 weeks. The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland Adaptive Behavior Scales (VABS), communication, daily living skills, and socialization. The VABS was chosen because the impact of an agent on adaptive functioning in real life is even more important for obtaining a better quality of life than just alleviation of some symptoms. The raw scores from the interview can be also expressed as an age-equivalent score and a standard score compared with those of the subject's peers. There are also supplementary special norms for individuals with autism. Although standard scores could be more useful in subject characterization, their use as an outcome measure has been proven to be less sensitive due to floor effects and reduced variability, especially in short time periods, and thus these scores underestimate change. Conversely, scores of special norms tend to overestimate change, as a small increase in a raw score can produce a big improvement in special norm percentile rank. Thus, raw scores and age-equivalent scores seem to be the most appropriate for use as outcome measures, with the latter being more easily interpreted as change over time. Secondary outcomes included the Aberrant Behavior Checklist (ABC), the Autism Treatment Evaluation Checklist (ATEC), and the Clinical Global Impression-Improvement score (CGI-I). To explore other possible effects of the formulation not captured from the aforementioned instruments, we chose to record any other benefits observed and reported by the parents during its use. For this, the primary clinician (K.F.) conducted telephone or in-person interviews of the parents, independently of the assessing clinician (A.T.), to discuss the possible gains of the child. CGI-I was also independently coded by the primary clinician with personal assessments as well as with information gathered by parents and, in the majority of cases, by the subjects' trainers. Compliance was monitored by softgel capsule count and the parents' assurance that the capsules had actually been taken at each visit; in case of a capsule count <85% of the prescribed dosage at midterm and at the end of the study, the subject was excluded from the final analysis. Adverse events were systematically recorded on an adverse event form by using scales indicating severity, relationship to the study procedures, action taken, and any therapy required.

NCT ID: NCT01844466 Completed - Stroke Clinical Trials

Correlation of Visual and Motor Deficits in Stroke Patients

Start date: January 2012
Phase: N/A
Study type: Interventional

This is a prospective study of patients with stroke with accompanying motor and visual deficits. There will be patients' evaluations at 2 time points at the acute and subacute period after the stroke. Statistical correlation of the improvement of their deficits will be conducted