PubMed Health⌕ Search

Biomedical subjects

Michael Friedman

Publications and source records attributed to Michael Friedman.

At least 19 recordsLinked to original sources
PubMed2006

Soluble sustained release gene delivery system.

Delivery of genetic substance to target cells remains an obstacle for efficient utilization of gene therapy approaches. In this study, we describe a formulation of methacrylate acid copolymer carrier of DNA, in which the release rate of the gene can be controlled by pH. Plasmid release was coupled with the polymer's dissolution, which was accelerated in alkali conditions. The released plasmid was intact and bioactive, although alteration from closed circular supercoil to relaxed conformation was observed. Confocal laser scanning microscopy detected the plasmid DNA along the central layers of the polymeric film. Gene delivery systems controlled by the dissolution of the polymeric films offer flexibility in quantity and size of the incorporated DNA, and therefore could have a potential for in vivo use.

Biocompatible Materials↗
PubMed2006

The impact of gender, age and depressed state on patients' perspectives of remission.

BACKGROUND: Current standards for treatment outcome from major depression assess remission solely from the vantage point of symptom resolution. Recent evidence, however, suggests that depressed patients consider factors beyond symptom resolution as important for defining remission. The goal of this study was to examine the influence of three predictors on patients' views of factors important for achieving remission: gender, age and current depressed state (i.e., remitted or depressed). METHODS: Five hundred and sixty-two depressed psychiatric outpatients completed a survey assessing the importance of 16 remission factors. Depressed state was assessed by the Standardized Clinical Outcome Rating scale for Depression (SCOR-D), a clinician rated scale that is based on the number of DSM-IV criteria for a major depressive episode and level of psychosocial impairment present during the past week. RESULTS: Relative to male patients, females showed a greater likelihood for rating remission factors related to emotional stabilization (e.g., achieving emotional control, being able to cope with normal stress) as very important. Relative to younger cohorts, the oldest depressed patients endorsed a greater number of remission factors as very important and emphasized positive mental health states (e.g., feeling satisfied, having a general sense of well-being) more. There were no significant differences between remitted and depressed patients in rating the remission factors' importance. CONCLUSION: Perspectives on remission may be differentially perceived by women versus men and by older versus younger depressed patients. LIMITATIONS: The study was conducted in a single outpatient clinical practice.

Adolescent↗
PubMed2006

Gastroretentive Accordion Pill: Enhancement of riboflavin bioavailability in humans.

The purpose of this study was to evaluate the ability of the Accordion Pill (AP), a novel controlled release gastroretentive unfolding dosage form (DF), to increase the bioavailability of riboflavin (RF) in humans. Three formulations containing 75 mg of RF and differing in release rate (immediate release (IR) capsule, AP#1, and AP#2) were administered with a low-calorie meal. Gastric residence time (GRT) of the AP was assessed by magnetic resonance imaging. Serial blood and urine samples were taken and assayed for RF. The AP demonstrated prolonged (up to 10.5 h) GRT in humans. Significant elevation in RF bioavailability (209+/-37%, mean+/-S.E.) was achieved by the AP#1 in comparison to the IR capsule. A correlation was established between the in-vitro release rates from DF and bioavailability of RF in humans, and it was modeled taking into account the saturable nature of RF absorption transport and its narrow absorption window (NAW) in the upper gastro-intestinal tract. It is anticipated that the AP will provide a valuable pharmaceutical solution to enhance therapy with NAW drugs.

Administration, Oral↗
PubMed2006

Discordance between self-reported symptom severity and psychosocial functioning ratings in depressed outpatients: implications for how remission from depression should be defined.

The diagnosis of depression is based on the presence of symptoms along with functional impairment. One might therefore expect the definition of remission of depressive disorder to be based on the resolution of both symptoms and functional impairments. This, however, is not how the field has been defining remission. Rather, in treatment studies of depression, remission has been defined in symptom terms only. Clinical experience suggests that there is sometimes discordance between patients' symptom severity and functioning. No studies, however, have examined the frequency of this discordance. We examined the concordance of ratings of depression symptom severity and psychosocial functioning in a sample of 503 outpatients receiving treatment for major depressive disorder. The majority of patients were concordant in these ratings (i.e. no symptoms and no functional impairment, or ongoing symptoms and impairment), though one quarter of the patients were discordant. Specifically, approximately one quarter of the patients with depressive symptoms denied concurrent psychosocial impairment. In contrast, it was rare for patients without symptoms to report functional impairment. Almost all patients without both symptoms and functional impairment considered themselves to be in remission, and almost all patients with both symptoms and functional impairment did not consider themselves to be in remission. Half of the patients who reported normal functioning despite ongoing depressive symptoms considered themselves to be in remission from their depression. This suggests that current symptom-based definitions of remission might be too narrow.

Adult↗
PubMed2006

Sustained-release delivery systems of triclosan for treatment of Streptococcus mutans biofilm.

Dental diseases are chronic infections caused by oral bacteria harboring the dental biofilm. Local sustained-release delivery systems prolong the duration of a drug in the oral cavity, thus enhancing its therapeutic potential, while reducing its side effects. Triclosan is an agent that was found to have an antibacterial effect against oral bacteria. However, its substantivity in the oral cavity is low, resulting in reduced antibacterial efficiency. The purpose of this study was to develop a local sustained release device containing triclosan and to test its antibacterial efficacy on Streptococcus mutans biofilm. Our results show that we can formulate an ethylcellulose-based, nondegradable, sustained-release device in which 80% of the loaded triclosan is released over a 10-day period. The release rate of triclosan corresponded to the Higuchi's planar homogenous diffusion release model (r2 = 0.998). A degradable local sustained-release delivery based on a methacrylate ester matrix was also developed for a faster release rate of triclosan. The release kinetics in those types of sustained-release delivery systems was erosion control. The local sustained-release delivery system significantly affected the viability of S. mutans in biofilm compared to placebo as was tested by confocal laser scanning microscopy. Our in vitro results show that triclosan can be incorporated into degradable or nondegradable sustained-release drug delivery systems. The release of triclosan from the local sustained-release delivery system can be controlled, thus extending its antibacterial properties.

Biodegradation, Environmental↗
PubMed2006

A targeted endoscopic approach to chronic isolated frontal sinusitis.

OBJECTIVE: Chronic isolated frontal sinusitis occurs infrequently. In this condition, most of the ethmoid cells are well aerated and the frontal sinus is involved secondary to anatomical obstruction or inflammatory changes confined to the frontal recess. The purpose of this study was to evaluate a targeted endoscopic technique where standard anterior ethmoidectomy is unnecessary in the treatment of chronic isolated frontal sinusitis. STUDY DESIGN AND SETTING: This retrospective study was conducted in a large university-affiliated hospital and included 11 patients with chronic isolated frontal sinusitis who underwent endoscopic sinus surgery limited to the frontal sinus outflow. The ethmoid bulla was untouched in all cases. Follow-up continued for 19 to 40 months (mean 28.6 months). RESULTS: Frontal sinus outflow patency was verified in 9 patients (81.8%). Nine patients, including one with an apparent nonpatent frontal ostium, reported improvement. Two patients-one of whom had a patent frontal ostium-reported no improvement. There were no complications. CONCLUSION: Chronic isolated frontal sinusitis can be effectively treated in selected cases by a targeted endoscopic procedure, limited to reestablishment of frontal sinus outflow. EBM RATING: C-4.

Adult↗
PubMed2006

Patient selection and efficacy of pillar implant technique for treatment of snoring and obstructive sleep apnea/hypopnea syndrome.

OBJECTIVE: Pillar implant (PIT) is a simple, office-based procedure with minimal morbidity that was introduced in 2003 to treat snoring and mild/moderate obstructive sleep apnea/hypopnea syndrome (OSAHS). We studied the: (1) success rate using subjective symptoms and objective polysomnographic improvement; (2) success rate based on BMI, OSAHS severity and Friedman tongue position (FTP); and (3) its value as an adjunctive or revision procedure. STUDY DESIGN AND SETTING: Retrospective review of 125 patients who underwent the PIT for snoring and OSAHS. Patients were grouped: Group I had PIT only (n = 29); Group II received adjunctive nasal procedures (n = 37), Group III received adjunctive oropharyngeal procedures (n = 55); and Group IV had failed previous UPPP (n = 4). RESULTS: Overall subjective and objective "cure" rates were 88.0% and 34.4%, respectively. Group IIb had the best objective cure rate of 46.7%. Neither AHI nor BMI correlated with outcome measures, whereas FTP did correlate. (FTP I and II had improved success vs FTP III and IV). Ten patients had partial extrusion of the PIT. These were removed and new PIT were carried out at a later date. CONCLUSIONS: Based on a short-term study, the Pillar implant is an effective treatment for snoring and OSAHS in selected patients and can be combined with adjunctive procedures to treat OSAHS.

Adolescent↗
PubMed2006

Reduction of C-reactive protein with surgical treatment of obstructive sleep apnea hypopnea syndrome.

OBJECTIVES: To determine whether surgical treatment of obstructive sleep apnea/hypopnea syndrome (OSAHS) has an impact on C-reactive protein (CRP) level. STUDY DESIGN: Prospective study of 34 consecutive subjects undergoing surgical treatment for OSAHS. CRP levels were evaluated preoperatively and 2 months postoperatively. The most commonly performed procedure was uvulopalatopharyngoplasty (UPPP) combined with radiofrequency tongue base reduction. RESULTS: Seven patients were treated for mild OSAHS and 23 were treated for moderated/severe OSAHS; 18 of 23 patients with moderate/severe disease had relative elevation of preoperative CRP levels. Mean CRP level decreased from 0.33 mg/dL preoperatively to 0.16 mg/dL postoperatively (P=0.003). Even patients who did not achieve complete "cure" by classical polysomnography (PSG) criteria may benefit from lowered CRP levels. All patients, however did achieve reduction in apnea hypopnea index and improvement in clinical symptoms. CONCLUSIONS: Levels of CRP were elevated preoperatively but decreased after surgical treatment. Therefore, OSAHS surgical treatment may be useful in reduction of CRP levels in patients who will not or cannot accept nasal-CPAP therapy.

Adult↗
PubMed2006

Comparison of the incidences of obstructive sleep apnea-hypopnea syndrome in African-Americans versus Caucasian-Americans.

OBJECTIVE: To determine the relative incidence of obstructive sleep apnea-hypopnea syndrome (OSAHS) in African-Americans compared to a cohort of Caucasian-Americans. STUDY DESIGN AND SETTING: A prospective study of 2 groups of subjects (287 African-Americans and 236 Caucasian-Americans) to evaluate OSAHS severity based on subjective symptoms and anatomic findings. Subjects were from a public health and fitness fair attended by approximately 80,000 people where attendees were invited for an ENT screening. RESULTS: Using OSAHS scores based on subjective symptoms and anatomic findings, the African-American group had a significantly higher incidence of "probable" OSAHS. In addition to symptoms of OSAHS, the questionnaire ascertained that African-American bed partners are more likely to accept loud snoring as compared to Caucasian-American bed partners. CONCLUSIONS: OSAHS may be more common in African-Americans, but African-American bed partners are more likely to accept snoring. The medical community should strive to increase awareness and education about OSAHS in the African-American community. EBM RATING: B-3b.

Adolescent↗
PubMed2006

The validity of the neuropathic pain scale for assessing diabetic neuropathic pain in a clinical trial.

OBJECTIVES: In controlled trials of analgesics for the treatment of neuropathic pain, the primary outcome variable is most often a measure of global pain intensity. However, because neuropathic pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed. This study sought to evaluate the utility of assessing the multiple components of neuropathic pain in an analgesic clinical trial. METHODS: One hundred fifty-nine subjects with diabetes-related foot pain were randomly assigned to receive an active analgesic (controlled-release oxycodone) or matching placebo for 6 weeks. A multidimensional measure of neuropathic pain, the Neuropathic Pain Scale (NPS), was administered before, during, and after study treatment. RESULTS: Relative to placebo, the opioid analgesic produced statistically significantly greater decreases in global pain intensity, pain unpleasantness, and sharp, dull, and deep pain sensations. Responder analyses indicated a higher rate of responding to the opioid condition, relative to placebo, for intense, unpleasant, deep, and surface pain. The opioid analgesic did not significantly reduce hot, cold, itchy, or sensitive pain sensations compared with placebo in either analysis. CONCLUSIONS: These findings support the utility of the NPS for characterizing the multidimensional nature of the neuropathic pain experience and for detecting changes in neuropathic pain with treatment.

Adult↗
PubMed2006

Long-term results after endoscopic sinus surgery involving frontal recess dissection.

OBJECTIVE: To assess long-term follow-up on a cohort of patients who underwent endoscopic frontal sinus surgery with identification and preservation of the natural frontal outflow tract. STUDY DESIGN AND SETTINGS: Retrospective chart review, telephone interview, and endoscopic evaluation on a previously studied cohort of patients at a university affiliated medical center. RESULTS: Two hundred patients who underwent endoscopic frontal sinus surgery were previously studied and reported after short-term (mean = 12.2 mo) follow-up. One hundred fifty-two (76%) patients were available for long-term (mean 72.3 mo) follow-up and assessment of subjective symptoms. Fifty-seven of 152 (37.5%) patients also had nasal endoscopy for evaluation of objective findings. The percentage of patients responding to telephone interview reporting overall improvement after surgery was 92.4%. Endoscopic assessment revealed patency of the frontal sinus in 67.6% of the patients after initial surgery. Thirteen additional patients had patent sinuses after revision procedures, bringing overall patency rate to 71.1%. We found statistically significant correlation of asthma and smoking and poor subjective and objective outcome. CONCLUSION: Long-term assessment of subjective and objective findings in our previously reported cohort of patients who underwent frontal sinus surgery indicates that the frontal sinus, similar to any other sinus, can be successfully treated surgically by preserving the natural frontal sinus outflow tract.

Adolescent↗
PubMed2006

A randomized, prospective, double-blind study on the efficacy of dead sea salt nasal irrigations.

OBJECTIVE: The objective of this randomized, prospective, double-blind study was to compare nasal irrigation using hypertonic Dead Sea salt (DSS) solution with hypertonic saline in the treatment of chronic rhinosinusitis and improvement of quality of life (QOL). METHODS: With Institutional Review Board approval, 42 adults seeking treatment for chronic rhinosinusitis in a tertiary university-affiliated medical center were studied. After history and endonasal examination, computed tomography imaging, and QOL survey (Standardized Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)]), patients were randomized to self-administered hypertonic saline spray and irrigation twice daily or hypertonic DSS spray and irrigation. Patients were reassessed weekly and at 1 month. RESULTS: Both groups had similar symptoms and RQLQ(S) scores before treatment and had significant improvement after treatment. However, the DSS patients had significantly better symptom relief and only the DSS group showed improved RQLQ(S) scores. CONCLUSIONS: We present a short-term study providing level I evidence on the superiority of DSS over saline nasal irrigation for treatment of chronic rhinosinusitis.

Adolescent↗
PubMed2006

Palatal stiffening after failed uvulopalatopharyngoplasty with the Pillar Implant System.

OBJECTIVE/HYPOTHESIS: The objective of this study was to measure subjective and objective improvement after palatal stiffening in patients after uvulopalatopharyngoplasty (UPPP) who were experiencing persistence or recurrence of snoring with or without daytime sleepiness symptoms. STUDY DESIGN: The authors conducted a prospective, nonrandomized study of 26 patients after UPPP who underwent the Pillar Implant Technique (PIT) as a revision procedure. METHODS: Patients were selected to undergo revision PIT if they presented with recurrence or persistence of snoring after UPPP. Patients had mild or moderate obstructive sleep apnea-hypopnea syndrome (OSAHS) (apnea-hypopnea index [AHI] >5 and < or =40), persistent retropalatal obstruction, and a residual palate > or =2 cm. Some patients experienced daytime somnolence as well. Patients with severe OSAHS (AHI > or =40), Friedman anatomic stage IV, and/or nasopharyngeal stenosis were excluded. Pre-/postoperative snoring levels, Epworth Sleepiness Scale (ESS), SF-36v2 Quality of Life (QOL) questionnaires, and polysomnograms were obtained. RESULTS: We completed data on 23 patients. Postoperative snoring levels (3.4 +/- 1.8) and ESS (8.7 +/- 1.8) significantly improved (P < .0001) compared with preoperative values (8.7 +/- 1.8 and 13.2 +/- 2.9). A total of 73.9% of patients improved subjectively. Seven of eight SF-36v2 QOL domains showed significant improvement (P < .05). Postoperative AHI and minimum oxygen saturation also improved significantly (P < .05). Objective cure was only achieved in 21.7% of patients. CONCLUSIONS: Revision PIT is effective in achieving subjective improvement of recurrent symptoms after UPPP. Objective cure was only obtained in 21.7% of patients. As a result of the safety and low morbidity of the procedure, it is an alternative to improve symptoms, especially snoring, in patients not willing to accept continuous positive airway pressure permanently or patients who refuse revision surgery.

Adult↗
PubMed2006

How should remission from depression be defined? The depressed patient's perspective.

OBJECTIVE: Although experts in the treatment of depression have suggested that achieving remission is the primary goal of treatment, questions remain about how remission should be defined. In antidepressant efficacy trials, remission is defined according to scores on symptom severity scales. Normalization of functioning is often mentioned as an important component of remission, although it is not used to identify patients with remission in treatment studies. The authors' goal was to determine what depressed patients consider important in defining remission from depression. METHOD: A brief questionnaire was distributed to 535 psychiatric outpatients who were being treated for DSM-IV major depressive episode. They were asked to rate the importance of 16 statements in determining whether depression is in remission. RESULTS: The three items most frequently judged to be very important in determining remission were the presence of features of positive mental health such as optimism and self-confidence; a return to one's usual, normal self; and a return to usual level of functioning. The patients endorsed a statement about absence of symptoms with nearly similar frequency. CONCLUSIONS: Patients aspire to a range of outcomes from the treatment of their depression.

Adult↗
PubMed2006

Developing brief scales for use in clinical practice: the reliability and validity of single-item self-report measures of depression symptom severity, psychosocial impairment due to depression, and quality of life.

OBJECTIVE: Reliable, valid, user-friendly measurement is necessary to successfully implement an outcomes evaluation program in clinical practice. Self-report questionnaires, which generally correlate highly with clinician ratings, are a cost-effective assessment option. However, even self-administered questionnaires can be burdensome to patients because many are lengthy. Consequently, we developed and determined the reliability and validity of ultra-brief, single-item assessments of 3 domains important to consider when treating depressed patients: symptom severity, psychosocial functioning, and quality of life. METHOD: In the first study (conducted June 1997 to March 2002), 1278 psychiatric outpatients with various DSM-IV diagnoses completed single-item assessments of psychosocial functioning and quality of life as well as more detailed measures of these constructs. In the second study (conducted August 2003 to July 2004), 562 psychiatric outpatients who were in ongoing treatment for a DSM-IV major depressive episode completed a depression symptom scale and a measure of global severity of depression. RESULTS: The test-retest reliability of the psychosocial functioning and quality-of-life items was high. The single-item measures of symptom severity, psychosocial functioning, and quality of life were significantly correlated with the total scores and individual item scores of longer measures of the same constructs (p < .001). The single-item measures significantly discriminated between depressed patients in full remission, in partial remission, and in a current depressive episode (p < .001). CONCLUSION: These studies provide evidence of the reliability and validity of single-item measures of symptom severity, psychosocial functioning, and quality of life. Very brief measures, such as the ones described in the present report, are not burdensome for patients to complete and can be easily incorporated into a busy clinical practice in order to collect data on treatment effectiveness.

Adaptation, Psychological↗
PubMed2006

Supraphysiological cyclic dosing of sustained release T3 in order to reset low basal body temperature.

The use of sustained release tri-iodothyronine (SR-T3) in clinical practice, has gained popularity in the complementary and alternative medical community in the treatment of chronic fatigue with a protocol (WT3) pioneered by Dr. Denis Wilson. The WT3 protocol involves the use of SR-T3 taken orally by the patient every 12 hours according to a cyclic dose schedule determined by patient response. The patient is then weaned once a body temperature of 98.6 degrees F has been maintained for 3 consecutive weeks. The symptoms associated with this protocol have been given the name Wilson's Temperature Syndrome (WTS). There have been clinical studies using T3 in patients who are euthyroid based on normal TSH values. However, this treatment has created a controversy in the conventional medical community, especially with the American Thyroid Association, because it is not based on a measured deficiency of thyroid hormone. However, just as estrogen and progesterone are prescribed to regulate menstrual cycles in patients who have normal serum hormone levels, the WT3 therapy can be used to regulate metabolism despite normal serum thyroid hormone levels. SR-T3 prescription is based exclusively on low body temperature and presentation of symptoms. Decreased T3 function exerts widespread effects throughout the body. It can decrease serotonin and growth hormone levels and increase the number of adrenal hormone receptor sites. These effects may explain some of the symptoms observed in WTS. The dysregulation of neuroendocrine function may begin to explain such symptoms as alpha intrusion into slow wave sleep, decrease in blood flow to the brain, alterations in carbohydrate metabolism, fatigue, myalgia and arthralgia, depression and cognitive dysfunction. Despite all thermoregulatory control mechanisms of the body and the complex metabolic processes involved, WT3 therapy seems a valuable tool to re-establish normal body functions. We report the results of 11 patients who underwent the WT3 protocol for the treatment of CFS. All the patients improved in the five symptoms measured. All patients increased their basal temperature. The recovery time varied from 3 weeks to 12 months.

Body Temperature↗
PubMed2005

Lifestyle management of erectile dysfunction: the role of cardiovascular and concomitant risk factors.

The influence and significance of lifestyle factors in erectile dysfunction (ED) have been demonstrated in cross-sectional and prospective, randomized, controlled trials. Recent epidemiologic studies in several countries have shown that modifiable lifestyle or risk factors, including physical activity in particular, are directly related to the occurrence of ED. In this article, we review several recent observational studies, 2 of which include a longitudinal follow-up component in the study design. The levels of physical activity in both of these studies predicted ED prevalence and incidence. Furthermore, the role of lifestyle changes (weight loss, physical activity) were recently demonstrated to be effective in modifying ED in a prospective, randomized Italian trial in moderately obese, sedentary men. Men without overt diabetes mellitus or cardiovascular disease participated in this landmark study. Other studies have shown that aggressive management of cardiovascular risk factors can increase the effectiveness or outcomes associated with pharmacologic management of ED. Taken together, these studies support the value of risk factor modification and lifestyle change in the clinical management in men with ED and concomitant cardiovascular illness.

Cardiovascular Diseases↗