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At least 469 records · Page 26Linked to original sources
PubMed1996

Effects of pegorgotein on neurologic outcome of patients with severe head injury. A multicenter, randomized controlled trial.

OBJECTIVE: To evaluate outcome of patients with severe closed head injury treated with pegorgotein, a scavenger of oxygen-derived free radicals. DESIGN: Randomized, parallel, placebo-controlled, third-party-blind, multicenter trial, with a blinded, multicenter follow-up protocol. SETTING: Twenty-nine centers in the United States. PATIENTS: A total of 463 patients with severe closed head injury and a Glasgow Coma Scale score of 8 or less after resuscitation and stabilization. INTERVENTIONS: Patients received a single intravenous dose of placebo, 10 000 U/kg of pegorgotein, or 20 000 U/kg of pegorgotein within 8 hours after injury. OUTCOME MEASURES: The primary endpoint was the Glasgow Outcome Scale (GOS) score at 3 months after brain injury with GOS data trichotomized into good, fair, or poor outcome. Secondary efficacy endpoints included the Disability Rating Scale (DRS) and mortality. A secondary analysis was performed using GOS scores dichotomized into favorable and unfavorable outcomes. In a follow-up protocol at 6 months, GOS and DRS scores were again determined. RESULTS: Of 463 patients randomized, 162 received placebo; 149, pegorgotein 10 000 U/kg; and 152, pegorgotein 20 000 U/kg. Treatment groups were comparable with respect to demographic characteristics, mechanism of injury, and time to treatment. Pegorgotein was well tolerated at both dose levels. At month 3, the trichotomized analysis found no significant statistical difference in neurologic outcome between the pegorgotein and the placebo groups. Although differences were not statistically significant, there were more favorable outcomes and no increase in the number of deaths or vegetative states among the patients given pegorgotein, more subjects had good or favorable outcomes with the 10 000-U/kg dose than with the 20 000-U/kg dose or placebo, and less disability was observed with the 10 000-U/kg dose than with either the 20 000-U/kg dose or placebo. No differences in mortality rate or cause of death were found between the 10 000-U/kg and placebo groups at either month 3 or month 6. The only statistically significant difference between the groups was a decreased incidence of adult respiratory distress syndrome in the 10 000-U/kg group as compared with the placebo group (P<.015). CONCLUSIONS: In this clinical trial of 463 patients with severe head injury, no statistically significant difference in neurologic outcome or mortality was observed between patients treated with pegorgotein and those receiving placebo.

Adolescent↗
PubMed1996

Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group.

OBJECTIVE: To assess the safety and efficacy of Seprafilm (HAL-F), Bioresorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after myomectomy. DESIGN: Prospective, randomized, blinded, multicenter study. Adhesion reduction was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's second-look laparoscopy. SETTING: Nineteen institutions across the United States. PATIENT(S): One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision > or = 1 cm in length. INTERVENTION(S): Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy. MAIN OUTCOME MEASURE(S): The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy. RESULT(S): The incidence, measured as the mean number of sites adherent to the uterine surface, was significantly less in treated patients (4.98 +/- 0.52 [mean +/- SEM] sites) than in no treatment patients (7.88 +/- 0.48 sites) as were the mean uterine adhesion severity scores (1.94 +/- 0.14 versus 2.43 +/- 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 +/- 0.12 versus 1.68 +/- 0.10), and mean area of adhesions (13.2 +/- 1.67 versus 18.7 +/- 1.66 cm2). No adverse events occurred that were judged to be related to the use of Seprafilm. CONCLUSION(S): In this multicenter study, treatment of patients after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complications.

Adult↗
PubMed1996

Percentage of inadequate phlebograms and observer agreement in thromboprophylactic multicenter trials using standardized methodology and central assessment.

This study examines inadequacy rates for phlebography in two multicenter trials for the prevention of post-operative DVT and determines inter-and intra-observer variability in evaluating phlebograms. A total of 991 (I) and 385 (II) patients underwent bilateral phlebography in two studies of thromboprophylaxis. Phlebography was performed using a standard method designed to visualize and assess all deep veins. Each vein was scored as normal, DVT or inadequate by both local and central assessment. The study showed low inadequacy rates for phlebograms of 12.2% (121/991) and 6.5% (25/385). Inter-observer agreement (local vs. central assessment) was moderate in both studies (I: 74.8%, Kappa-value 0.41; II: 82.6%, Kappa-value 0.51). Good intra-observer agreement (within the central assessment group) was observed (I:88.8%, Kappa-value 0.75). This study demonstrates low inadequacy rates for phlebograms using a standardized methodology and superior intra-observer agreement compared to inter-observer agreement and supports the importance of central assessment of phlebograms in thromboprophylactic multicenter trials to reduce observer variability.

Clinical Trials as Topic↗
PubMed1997

Tacrolimus in pancreas transplantation: a multicenter analysis. Tacrolimus Pancreas Transplant Study Group.

This follow-up multicenter analysis is based on 362 pancreas allograft recipients at 14 institutions who were given tacrolimus between 1 May 1994 and 15 November 1995. Three groups were studied: (1) recipients given tacrolimus initially for induction and maintenance therapy (n = 250; 215 without, 35 with, a concurrent bone marrow transplant), (2) recipients who converted to tacrolimus for rescue or rejection therapy (n = 89), and (3) recipients who converted to tacrolimus for other reasons (n = 23). Of 215 recipients without a bone marrow transplant in the induction group, 166 (77%) underwent a simultaneous pancreas-kidney transplant (SPK), 29 (14%) a pancreas transplant alone (PTA), and 20 (9%) a pancreas after previous kidney transplant (PAK). Initial antibody therapy was given to 185 (86%) recipients. All 215 received tacrolimus and prednisone; 202 (94%) also received azathioprine (AZA) and 11 (5%) mycophenolate mofetil (MMF). The most common side effects of tacrolimus were neurotoxicity in 21%, nephrotoxicity in 21%, gastrointestinal (GI) toxicity in 13%, and diabetogenicity in 13% of these recipients. No recipient in this group developed new-onset insulin-dependent diabetes mellitus. Of 89 recipients in the rescue group, 71 (79%) had an SPK, 11 (13%) a PTA, and 7 (8%) a PAK. Before conversion, all had been on cyclosporine (CsA)-based immunosuppression; 74% of them had 2 or more rejection episodes previously. The most common side effects were nephrotoxicity in 27%, neurotoxicity in 26%, GI toxicity in 18%, and diabetogenicity in 8% of these recipients. No recipient in this group developed new-onset insulin-dependent diabetes mellitus. In the induction group patient survival at 1 yr was 98% for SPK, 79% for PTA, and 100% for PAK recipients. According to a matched-pair analysis, pancreas graft survival for SPK recipients at 1 yr was 88% with tacrolimus vs. 73% with CsA (p = 0.002); for PTA recipients, 68% vs. 70% (p > 0.35); and for PAK recipients, 85% vs. 65% (p = 0.13). Graft loss from rejection was not different with tacrolimus vs. CsA in all 3 pancreas recipient categories. At 1 yr, 17% of recipients had converted from tacrolimus to CsA for diabetogenicity, nephrotoxicity, or rejection; 23% had converted from AZA to MMF. The incidence of post-transplant lymphoma was < 2%. In the rescue group, patient survival rates at 1 yr were 96% for SPK, 100% for PTA, and 86% for PAK recipients (p < 0.08). Pancreas graft survival at 1 yr was 89% for SPK, 58% for PTA, and 69% for PAK recipients (p = 0.004). Graft loss from rejection was significantly lower for SPK vs. PTA or PAK recipients. At 1 yr, 20% of recipients had reconverted from tacrolimus to CsA for rejection, neurotoxicity, or nephrotoxicity; 19% had converted from AZA to MMF. There were no post-transplant lymphomas in the rescue group. This follow-up multicenter analysis shows that tacrolimus after pancreas transplantation is associated with high graft survival rates when used for induction and with high graft salvage rates when used for rescue therapy. The rate of graft loss from rejection is low in all 3 pancreas recipient categories. The overall incidence of new-onset insulin-dependent diabetes mellitus is < 1%, as is the incidence of post-transplant lymphoma. Converting from tacrolimus to CsA and, in patients on tacrolimus, from AZA to MMF, is safe; interchangeable use of drugs appears to be of immunologic benefit. To determine the best immunosuppressive regimen after pancreas transplantation, a prospective randomized study comparing tacrolimus and MMF vs. Neoral plus MMF is mandatory.

Adult↗
PubMed1997

A multicenter study on the detection of prostate cancer by digital rectal examination and prostate-specific antigen in men with or without urinary symptoms. Cooperative Group for Diagnosis of Prostate Cancer.

OBJECTIVE: The use of prostate-specific antigen (PSA) for prostatic cancer screening and the practical utility of the concept of PSA density are controversial. The aim this multicenter study was to assess the usefulness of PSA as a diagnostic procedure for prostate cancer in patients with urinary symptoms, and compare it with digital rectal examination (DRE). METHODS: We performed a multicenter study in 18 hospitals to assess the value of PSA in the diagnosis of prostate cancer. 2,054 outpatients, aged above 50 years, were included in the study. Patients with suspected prostatitis or severe systemic disease were excluded. PSA levels were measured in all patients (IMx) and a DRE was also performed. Patients with PSA levels > 3 ng/ml and/or a suspicious DRE underwent transrectal ultrasound and a prostate biopsy. RESULTS: PSA levels > 3 ng/ml and/or a suspect DRE were found in 680 (33%) patients, in 587 (29%) of whom a biopsy was performed. A cancer of the prostate was diagnosed in 131 patients. The cancer detection rate was 5.89% for PSA > 4 ng/ml, 4.38% for DRE and 6.37% for the combination of both methods. The combination of PSA and DRE allows for increasing the diagnostic sensitivity which would be achieved with either test alone. CONCLUSION: We recommended the use of PSA and DRE in combination as a diagnostic procedure for prostate cancer, since these are complementary methods which allow for detecting a population at a high risk of suffering prostate cancer.

Aged↗
PubMed1997

On the value of large multicenter drug intervention trials.

Many large multicenter clinical drug trials are outcome trials with several thousand patients, therefore also called megatrials, numerous of which encompassing the cardiovascular field. Usually designed to test and compare the efficacy of a specific therapy with the major aim being improved outcome at hard end-points, specifically morbidity and mortality, they are representative of typical intervention trials. Considering also the risk of failure, examples of large multicenter therapy trials are examined as to their value to the patients, the society, the health care providers, and--finally--also the manufacturers of the respective drugs. The 'Syst-Eur Trial' (Systolic Hypertension in Europe) representing a very recent intervention trial to treat isolated high systolic blood pressure in elderly patients with treatment based on a calcium channel blocker, nitrendipine (CAS 39562-70-4, Bayotensin, Baypress), serves to indicate that besides the major end-point results, here total stroke rate, a number of important additional efficacy and safety results may be obtained with large trials, such as in this case favourable data on total mortality, myocardial infarctions, cancer, bleeding.

Cardiovascular Agents↗
PubMed1997

Paclitaxel (1-hour infusion) plus carboplatin in the treatment of advanced non-small cell lung cancer: results of a multicenter phase II trial.

This study was performed to determine the activity and toxicity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given by 1-hour infusion plus carboplatin in the treatment of patients with advanced non-small cell lung cancer when used in a multicenter, community-based setting. The study population included 100 chemotherapy-naive patientswith stage IIIB or IV non-small cell lung cancer, Karnofsky performance status 70 to 100, measurable disease, and adequate kidney, liver, and bone marrow function. All patients received paclitaxel 225 mg/m2 intravenously by 1-hour infusion followed immediately by carboplatin at a targeted area under the concentration-time curve of 6.0 (Calvert formula). Cycles were repeated every 21 days. Colony-stimulating factors were not used routinely. Thirty-eight (38%) of 100 patients had objective responses (38 [40%] of 94 evaluable patients) to treatment (three complete responses, 35 partial responses). Thirty-two other patients had stable disease at initial re-evaluation. Weight gain during treatment occurred in 47% of those patients with objective response or stable disease. The median survival among all 100 patients was 8 months, with a 1-year survival rate of 42%. Leukopenia was common, but hospitalization for treatment of neutropenia and fever occurred in only 3% of courses. Cumulative peripheral neuropathy occurred consistently, but usually after the third or fourth course; it was severe (grade 3) in only 15% of patients. Other grade 3 and 4 toxicity was uncommon. One patient died as a result of treatment due to sepsis. This large, multicenter, community-based phase II trial demonstrates the efficacy of paclitaxel/carboplatin combination chemotherapy in advanced non-small cell lung cancer. This regimen is relatively well tolerated and when paclitaxel is given by 1-hour infusion, this treatment is easily administered in the outpatient setting.

Adult↗
PubMed1995

Urgent ERCP in all cases of acute biliary pancreatitis? A prospective randomized multicenter study.

In this prospective multicenter study, the effect of early ERCP within 72 hours after the beginning of symptoms in the treatment of acute biliary pancreatitis was investigated. 100 patients with acute biliary pancreatitis but without biliary sepsis or obstructive jaundice were randomized in this trial. 48 patients of the invasive group received urgent ERCP within 72 hours after the beginning of pain. 52 patients of the conventional group received ERCP only if biliary sepsis or obstructive jaundice occurred during the clinical course of the disease (which was the case in 10 patients). Sphincterotomy and stone extraction were undertaken if bile duct stones were identified during ERCP. In the invasive group, ERCP was successfully performed in 44 cases (92%). In 19 of these patients (43%), common bile duct stones were identified and a sphincterotomy was performed. The stones could be removed completely during the first ERCP examination in 16 cases. In the conventional group, 2 patients died from pancreatitis within 3 months, versus 4 patients in the invasive group. Cholecystitis occurred significantly more often in the conventional group (11 versus 4; odds ratio OR = 5.1), but no patient with cholecystitis or cholangitis died. Cholangitis (OR = 3.3) and sepsis (OR = 3.5) were slightly more frequent in the conventional group (not significant) while renal failure (OR = 0.5) and pulmonary failure (OR = 0.8) were slightly more frequent in the invasive group (not significant). Jaundice (6 patients) only occurred in the conventional group. In this multicenter study, it is concluded that early ERCP is not superior to conventional treatment in patients with acute biliary pancreatitis. On the other hand, patients with biliary complications (jaundice, sepsis, cholangitis) should receive urgent ERCP. However, most bile duct stones which initiate a pancreatitis pass spontaneously into the duodenum. The vast majority of patients suffering from biliary pancreatitis without biliary sepsis or obstructive jaundice require only elective ERCP when remaining bile duct stones are assumed. The lethality of biliary pancreatitis without initial biliary complications (sepsis, jaundice) tends to be elevated rather than diminished by emergency ERCP.

Acute Disease↗
PubMedDate not supplied

[Simplified Ramírez urethropexy in the treatment of genuine stress urinary incontinence in women. Multicenter study of clinical and urodynamic results].

OBJECTIVES: To evaluate the clinical and urodynamic data of a multicenter study on female urinary stress incontinence undergoing surgical repair with the Ramírez simplified urethropexy. METHODS: Clinical, urodynamic and videocystographic data were analyzed in a multicenter series of 340 female patients with urinary stress incontinence (mean age 51.7 +/- 9.7 years) before and after the Ramírez urethropexy technique (mean follow-up 21.7 months). RESULTS: Post surgical urinary continence was 78.4%. Cystocele repair was demonstrated in 57.7%. Urge incontinence decreased in 17.1%. Daytime frequency statistically significantly decreased in 19%. Urinary obstructive symptoms increased in 19.3%. Bladder instability significantly decreased posturethropexy. Peak urinary flow rate and mean urinary flow rate diminished in 65% and 59%, respectively. Postvoiding residual urine increased significantly. No statistical correlation between posturethropexy continence and videocystographic bladder neck morphology was observed. CONCLUSIONS: The clinical and urodynamic data obtained in our series indicate that the Ramírez urethropexy technique, a simple and fast procedure, may be considered an alternative treatment in female urinary stress incontinence.

Adult↗
PubMed1997

Multicenter trial of transscleral diode laser retinopexy in retinal detachment surgery.

PURPOSE: To evaluate the safety and efficacy of transscleral diode laser for retinopexy in rhegmatogenous retinal detachment surgery in a multicenter trial. DESIGN: 67 patients with primary rhegmatogenous retinal detachment underwent scleral buckling surgery, using transscleral diode laser for retinopexy, at five study centers. STUDY PARTICIPANTS: 72 patients with primary rhegmatogenous retinal detachments were enrolled. No patient with chronic detachment, a retinal break greater than 90 degrees, history of uveitis or infectious retinopathy, or proliferative vitreoretinopathy was enrolled. Five eyes were excluded because they required additional nonprotocol treatment at the time of surgery (vitrectomy or supplementary cryotherapy due to probe malfunction). MAIN OUTCOME MEASURES: Retinal reattachment at six months after one operation. Secondary measures: visual acuity and complications, including choroidal, retinal, and vitreous hemorrhage, inflammation, and scleral damage. RESULTS: Six months or greater follow-up information was available on 65 eyes. Retinas were attached at 6 months with a single operation in 58 (89%) of these eyes. Complications included apparent pinpoint breaks in Bruch is membrane in 15 eyes, scleral thermal effect in 14 eyes, and limited hemorrhage, which was intraretinal in 10 eyes, and extended into the vitreous in 3 eyes. In one case, hemorrhage was judged to have contributed possibly to initial surgical failure. The other complications had no known adverse effects. Complications were significantly associated with the physicians experience with transscleral laser retinopexy. CONCLUSION: In this multicenter series, transscleral diode laser retinopexy served as a safe and effective means of creating chorioretinal adhesion during retinal reattachment surgery. Minor complications were minimized by increasing experience with the technique.

Adolescent↗
PubMed1998

Design of a clinical trial for the assessment of cardioversion using transesophageal echocardiography (The ACUTE Multicenter Study). Steering and Publications Committees of the ACUTE Study.

Patients with atrial fibrillation (AF) undergoing cardioversion are at an increased risk of cardioembolic stroke and require anticoagulation. The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) Multicenter Study is a randomized clinical trial of patients undergoing electrical cardioversion of AF of >2 days' duration comparing a transesophageal-guided strategy (TEE) with brief anticoagulation to the conventional anticoagulation strategy. Patients randomly assigned to the TEE-guided strategy receive therapeutic anticoagulation before TEE and cardioversion, followed by 4 weeks of anticoagulation. Patients with thrombus imaged by TEE have postponement of cardioversion, continue anticoagulation for 3 weeks, and undergo a repeat TEE. Conventional strategy patients receive 3 weeks of anticoagulation before cardioversion, followed by 4 weeks of anticoagulation after cardioversion. The primary end point events are ischemic stroke, transient ischemic attack, and systemic embolization for an 8-week period from enrollment. Secondary end points are major and minor bleeding, all-cause mortality, successful return to and maintenance of sinus rhythm, and cost effectiveness. Analysis is based on the intention-to-treat principle. The anticipated rates of embolism of 2.9% for conventional strategy and 1.2% for the TEE-guided strategy are based on published research and the completed pilot study. The ACUTE Multicenter Study will randomize therapy and follow an estimated 3,000 patients from 65 study sites to determine the relative efficacy of the TEE-guided and conventional approaches to electrical cardioversion for patients in AF. The results of this investigation will have important clinical implications for the management of patients with AF undergoing electrical cardioversion.

Adult↗
PubMedDate not supplied

Treatment of chronic hepatitis C genotype 4 with alpha-interferon in Saudi Arabia: a multicenter study.

BACKGROUND/AIM: Several studies have indicated that there are certain predictive factors (gender, duration of infection with HCV, cirrhosis and genotype of HCV) of a better response with alpha-interferon treatment in patients with chronic hepatitis C. The aim of this study was to evaluate these factors in Saudis and other Arab nationals with chronic hepatitis C-genotype 4-undergoing alpha-interferon treatment. METHODOLOGY: A multicenter study was conducted between 1992 and 1994 on 80 consecutive patients who were prospectively recruited and randomized in treatment and control groups. RESULTS: The results of this multicenter study indicated a low response rate to alpha-interferon with an overall response rate of 43%, of which 28% was complete. The sustained response was only 16%. Among the reasons for this low response in our study are the high percentage of patients with cirrhosis and the long infection interval, as about 80% of our HCV cases were community-acquired. CONCLUSION: Liver cirrhosis was found to be the main predetermining factor for response to interferon treatment. Genotype 4 was not a contributing factor to the difference in response rate.

Adult↗
PubMed1998

Methodologies and outcomes from the sertraline multicenter flexible-dose trials.

This article summarizes the results of a combined analysis from two identical multicenter clinical trials that investigated the efficacy and safety of sertraline versus placebo for treating panic disorder. Patients with panic disorder who were treated with sertraline had a statistically significant reduction in the mean number of panic attacks per week (the primary efficacy measure) as compared with placebo (4.8 vs. 2.5, p < .001). Sertraline-treated patients also showed greater improvement that was statistically significant on several ratings of panic disorder symptomatology and functioning. The design characteristics, clinical rating measures, and outcome measures in these trials included most of the features deemed essential by Shear and Maser (1994) in their summary of the NIMH Consensus Conference for the development of standardized assessments for panic disorder. This suggests that the NIMH Consensus Conference played a key role in developing successful multicenter pharmacological treatment studies, such as this one that ultimately demonstrated that sertraline was an effective treatment for panic disorder.

1-Naphthylamine↗
PubMed1998

Multicenter cooperative study group in hematology in Japan: the 10-year history and role of the Japan Adult Leukemia Study Group in Japan.

Leukemia is an uncommon disease. In order to conduct a scientific clinical study, a large number of patients is required for reliable statistical analysis, and therefore, multicenter cooperative study is indispensable in leukemia. Not only in the field of hematology/oncology but also in other fields of clinical medicine, well-functioning clinical study groups are still rare in Japan. In this review, the reason why the organization of multicenter cooperative study groups is difficult in Japan is analyzed. Then the 10-year experience of a self-supporting and quite successful cooperative study group, the Japan Adult Leukemia Study Group, is reviewed. Finally, the next steps for the Group and the way it might be successfully led are discussed.

Adult↗
PubMed1998

A multicenter study comparing dorzolamide and pilocarpine as adjunctive therapy to timolol: patient preference and impact on daily life.

BACKGROUND: A multicenter, 4-week, two-period crossover study, comparing 2% dorzolamide three times daily to 2% pilocarpine four times daily as adjunctive therapy to 0.5% timolol twice daily, was conducted on 81 patients with elevated intraocular pressure (IOP). The treatments were evaluated for patient preference, tolerability, impact on daily life, IOP control, and visual-field changes. METHODS: The Comparison of Ophthalmic Medications for Tolerability questionnaire was used to assess patient preference, as well as the perception of side effects and activity limitations resulting from the study medications. IOP measurements and visual-field examinations were obtained at baseline and at the end of each crossover period. RESULTS: Of the 77 patients who participated in both periods, 63 (82%) preferred dorzolamide. Patients who expressed a preference preferred dorzolamide over pilocarpine by a ratio of more than 10:1. Patients reported less interference with their daily life because of side effects and activity limitations while receiving dorzolamide than while receiving pilocarpine. Dorzolamide and pilocarpine were comparably effective in lowering IOP (16% to 17%). Also, significantly more patients reported adverse experiences and discontinued therapy as a result of adverse experiences while receiving pilocarpine than while receiving dorzolamide. CONCLUSION: The results of this multicenter study support those of two previous single-center studies; these results show that dorzolamide was greatly preferred over pilocarpine and had better tolerability and less adverse impact on patients' daily lives than pilocarpine.

Adrenergic beta-Antagonists↗
PubMed1998

Transscleral diode laser retinopexy in retinal detachment surgery: results of a multicenter trial.

PURPOSE: To evaluate the safety and efficacy of transscleral diode laser for retinopexy in rhegmatogenous retinal detachment surgery in a multicenter trial. METHODS: Seventy-two patients with primary rhegmatogenous retinal detachments were enrolled. No patient with chronic detachment, a retinal break greater than 90 degrees, history of uveitis or infectious retinopathy, or proliferative vitreoretinopathy was enrolled. RESULTS: Information from follow-up of 6 months or longer was available on 65 eyes. Retinas were attached at 6 months with a single operation in 58 (89%) of these eyes. Complications included apparent pinpoint breaks in Bruch's membrane in 15 eyes, scleral-thermal effect in 14 eyes, and limited hemorrhage, which was intraretinal in 10 eyes and extended into the vitreous in 3 eyes. In one case, hemorrhage was judged perhaps to have contributed to initial surgical failure. The other complications had no known adverse effects. Complications were significantly associated with the physician's experience in using transscleral laser retinopexy. CONCLUSIONS: In this multicenter study, transscleral diode laser retinopexy served as a safe and effective means of creating chorioretinal adhesion during retinal reattachment surgery. Minor complications were minimized by increasing experience with the technique.

Adolescent↗
PubMed2005

Safety and tolerability of denufosol tetrasodium inhalation solution, a novel P2Y2 receptor agonist: results of a phase 1/phase 2 multicenter study in mild to moderate cystic fibrosis.

Denufosol tetrasodium (INS37217) is a selective P2Y(2) agonist that stimulates ciliary beat frequency and Cl(-) secretion in normal and cystic fibrosis (CF) airway epithelia, and is being investigated as an inhaled treatment for CF. The Cl(-) secretory response is mediated via a non-CFTR pathway, and the driving force for Cl(-) secretion is enhanced by the effect of P2Y(2) activation to also inhibit epithelial Na(+) transport. Denufosol is metabolically more stable and better tolerated, and may enhance mucociliary clearance for a longer period of time than previously investigated P2Y(2) agonists. The goal of this phase 1/phase 2 study was to assess the safety and tolerability of single and repeated doses of aerosolized denufosol in subjects with CF. The study was a double-blind, placebo-controlled, multicenter comparison of ascending single doses of denufosol (10, 20, 40, and 60 mg, administered by inhalation via the Pari LC Star nebulizer) vs. placebo (normal saline), followed by a comparison of twice-daily administration of the maximum tolerated dose (MTD) of denufosol or placebo for 5 days. Thirty-seven adult (18 years of age or older) and 24 pediatric (5-17 years of age) subjects with CF were evaluated in five cohorts. Subjects were randomized in a 3:1 ratio to receive either denufosol or placebo within each cohort. The percent of subjects experiencing adverse events was similar between the denufosol and placebo groups. The most common adverse event in subjects receiving denufosol was chest tightness in adult subjects (39%) and cough in pediatric subjects (56%). Three (7%) subjects receiving denufosol and one (7%) subject receiving placebo experienced a serious adverse event. Forced expiratory volume in 1 sec (FEV(1)) profiles following dosing were similar across treatment groups, with some acute, reversible decline seen in both groups, most notably in subjects with lower lung function at baseline. In conclusion, doses up to 60 mg of denufosol inhalation solution were well-tolerated in most subjects. Some intolerability was noted among subjects with lower baseline lung function. Based on the results of this phase 1/phase 2 study, the Therapeutics Development Network (TDN) of the Cystic Fibrosis Foundation (CFF) and Inspire Pharmaceuticals, Inc., recently completed a multicenter, 28-day, phase 2 safety and efficacy clinical trial of denufosol inhalation solution in CF subjects with mild lung disease.

Administration, Inhalation↗
PubMed2000

Quality assessment in diagnostic molecular pathology: experience from a German-Austrian-Swiss multicenter trial.

In order to assess the current technical standard of diagnostic molecular pathology, we have conducted a multicenter trial with 34 participating pathology laboratories in Germany, Austria and Switzerland. Formalin-fixed, paraffin-embedded tissue blocks were selected from 15 cases, comprising 4 B-cell non-Hodgkin's lymphomas, 4 T-cell non-Hodgkin lymphomas, 4 cases with lymphadenitis, 2 cases with confirmed tuberculosis and 1 case of sarcoidosis. All participating laboratories received one 10-microm section from each of the 15 cases to detect clonality using immunoglobulin heavy chain (IgH) gene or T-cell receptor (TCR)-gamma gene rearrangement analysis in 12 and mycobacterial DNA in 3 cases. In addition, participants had to answer technical questions about the application of internal quality controls and performance of fragment length or sequence analysis. Correct results were reported in 80% and 90% for IgH and TCR-gammagene rearrangement analysis, respectively, and in 83% for mycobacterial DNA analysis. No significant differences in the quality of results were obvious when the individual techniques used for molecular analysis were compared. However, when two independent techniques were used by the same laboratory, a higher rate of correct results was obtained for IgH and TCR rearrangement analysis. In conclusion, this study demonstrates a high technical standard of molecular diagnostic adjuncts among the participating laboratories. Regular multicenter trials with a greater number of participating laboratories working in this field will be indispensable to ensure a continuing or increasing standard in diagnostic molecular pathology.

Austria↗