Intraoperative breakage of the mushroom manipulator tip during phacoemulsification.
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Equipment Failure↗
Biomedical subjects
R Goel
Publications and source records attributed to R Goel.
A phase I, first in man study of OSI-7836 in patients with advanced refractory solid tumors: IND.147, a study of the Investigational New Drug Program of the National Cancer Institute of Canada Clinical Trials Group.
PURPOSE: To determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), safety, tolerability, toxicity profile, dose-limiting toxicities (DLTs), anti-tumor activity and pharmacokinetics of OSI-7836 given IV on day 1 and day 8 every 3 weeks in patients with advanced incurable cancer. METHODS: Twenty-seven previously treated patients with advanced or metastatic solid tumors were enrolled in this phase I study conducted by the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG). OSI-7836 was administered IV on day 1 and day 8 every 3 weeks. The dose was initially escalated from 100 to 600 mg/m2 and finally de-escalated to 200 mg/m2 in seven cohorts of patients. Patients were evaluated every other cycle of treatment for radiological response. Pharmacokinetics were performed on day 1 and day 8 of cycle 1 for all patients. RESULTS: Twenty-six patients were evaluable for toxicity. All patients experienced reversible Grade 3 lymphopenia beginning at cycle 1. The maximal delivered dose was 600 mg/m2. MTD was reached at 400 mg/m2. DLTs included fever, fatigue, rash, herpes simplex infection, nausea and vomiting. The RP2D was 200 mg/m2. No objective responses were seen in 21 evaluable patients. Pharmacokinetics were dose proportional, with a mean half-life of 46.0 min and a clearance of 34 l/(h.m2). CONCLUSION: OSI-7836 given at 200 mg/m2 on day 1 and day 8 every 3 weekly is associated with manageable toxicity and is recommended for further study. While no objective responses were seen, the significant treatment related lymphopenia suggests that hematologic malignancies may warrant further investigation.
Adult↗
Phase I study of Aplidine in a dailyx5 one-hour infusion every 3 weeks in patients with solid tumors refractory to standard therapy. A National Cancer Institute of Canada Clinical Trials Group study: NCIC CTG IND 115.
BACKGROUND: Aplidine is a cyclic depsipeptide isolated from the marine tunicate Aplidium albicans. METHODS: This phase I study of Aplidine given as a 1-hour i.v. infusion daily for 5 days every 3 weeks was conducted in patients with refractory solid tumors. Objectives were to define the dose limiting toxicities, the maximal tolerated dose, and the recommended phase II dose. RESULTS: Thirty-seven patients were accrued on study. Doses ranged from 80 microg/m(2) to 1500 microg/m(2)/day. Eleven patients received more than three cycles of Aplidine. Dose-limiting toxicities occurred at 1500 microg/m(2) and 1350 microg/m(2)/day and consisted of nausea, vomiting, myalgia, fatigue, skin rash and diarrhea. Mild to moderate muscular pain and weakness was noted in patients treated with multiple cycles with no significant drug related neurotoxicity. Bone marrow toxicity was not observed. The recommended dose for phase II studies was 1200 microg/m(2) daily for 5 days, every 3 weeks. Pharmacokinetic studies performed during the first cycle demonstrated that therapeutic plasma levels of Aplidine are reachable well below the recommended dose. Nine patients with progressive disease at study entry had stable disease and two had minor responses, one in non-small cell lung cancer and one in colorectal cancer. CONCLUSIONS: Aplidine given at a dose of 1200 microg/m(2) daily for 5 days, every 3 weeks is well tolerated with few severe adverse events. This schedule of Aplidine is under evaluation in phase II studies in hematological malignancies and solid tumors.
Adolescent↗
Impact of cinematic viewing on endothelial function.
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Adult↗
An approach for substrate mapping between ASM and ADM1 for sludge digestion.
Kinetic modelling of the hydrolysis stage of municipal activated sludge, which is presumed to be the rate-limiting step in the anaerobic sludge digestion process, was studied by measuring methane production rate (MPR) in anaerobic batch tests. The MPR curves revealed that the degradable organic components in municipal sludge could be classified into two fractions having different kinetics. The first fraction (XS1) constituted about 55% of the sludge COD and degraded with first-order kinetics. The second fraction (XS2), which degraded during the initial phase, accounted for about 21% of sludge COD. The degradation kinetics for XS2 was expressed by Contois-type equation with respect to concentration of substrate in the fed sludge and that of active biomass in the mixture. Simultaneous batch aerobic respirometric tests showed that the activated sludge was composed of 53% heterotrophic biomass (XH-Aerobe) COD and 20% of slowly biodegradable COD (XS), that had same kinetic expressions as observed in the batch anaerobic tests. The observed correlation between substrate fractions suggests XS1 and XS2 could be directly mapped to the aerobic state variables of XH-Aerobe and Xs respectively. The degradation of XS1 seems to be anaerobic decay of XH-Aerobe while XS2 is thought to be hydrolysis of XS by microcosm of the sludge.
Anaerobiosis↗
A National Cancer Institute of Canada Clinical Trials Group Study--IND.135: Phase I/II study of irinotecan (camptosar), oxaliplatin and raltitrexed (tomudex) (COT) in patients with advanced colorectal cancer.
Thirty-one patients with metastatic colorectal cancer were enrolled in this phase I/II trial of a triple combination of camptosar (C), oxaliplatin (O) and tomudex (T), all given on day one of a convenient three-week schedule. Patients received 257 cycles (1-18) in five cohorts. Toxicity was manageable and haematological toxicity was mild to moderate. Diarrhoea was the main dose-limiting toxicity; nausea and vomiting were common. Fatigue was frequent, moderate in severity and a reason for discontinuation in some patients. The recommended phase II doses were (C) 220 mg/m(2), (O) 100mg/m(2), (T) 2.75 mg/m(2). A 50% response rate in 30 evaluable patients was confirmed by an independent radiology review board; progression-free survival and overall median survival were 7.3 months and 16.6 months, respectively. Of the 16 patients treated at the recommended dose, 9 (56.3%) experienced partial response. Further evaluation in a randomized study compared to sequential doublets is warranted. Triple combinations could be relevant in curative settings for high-risk patients.
Adult↗
An NCIC-CTG phase I dose escalation pharmacokinetic study of the matrix metalloproteinase inhibitor BAY 12-9566 in combination with doxorubicin.
BACKGROUND: This phase I study was performed to evaluate the safety, tolerability, and efficacy of the oral matrix metalloproteinase inhibitor BAY 12-9566 in combination with doxorubicin in patients with advanced solid tumours, and to identify the maximum tolerated dose of these agents in combination and the dose for use in subsequent studies. PATIENTS AND METHODS: 14 patients were entered onto 3 dose levels consisting of escalating doses of doxorubicin (50 mg/m(2), 60 mg/m(2) and 70 mg/m(2)) with 800 mg po bid BAY 12-9566. At all three dose levels, patients received doxorubicin alone in cycle one on day 1. Daily oral dosing with BAY 12-9566 was started on day 8 of cycle 1, and thus doxorubicin was given concurrently with BAY 12-9566 in cycle 2. Patients were continued on treatment until a dose limiting toxicity or tumour progression occurred. RESULTS: Pharmacokinetic studies from cycles 1 and 2 from the patients treated in the first three dose levels demonstrated that the addition of BAY 12-9566 increased the AUC(0-12h) levels of doxorubicin by a median of 48%. No effects were seen on the BAY 12-9566 pharmacokinetic values. Two dose limiting toxicities were seen at the third dose level. One patient experienced grade 3 stomatitis in cycle 2, and another patient experienced grade 4 granulocytopenia in cycle 1 and grade 4 thrombocytopenia in cycle 2. Thus the maximum tolerated dose of 60 mg/m(2) was declared. These toxicities were those that would have been expected from doxorubicin alone. CONCLUSIONS: BAY 12-9566 can be safely administered with full doses of doxorubicin without evidence of clinical interaction. The recommended dose of doxorubicin to be combined with BAY 12-9566 800 mg po b.i.d is 60 mg/m(2), however, further development of BAY 12-9566 has been abandoned.
Adult↗
An NCIC CTG phase I/pharmacokinetic study of the matrix metalloproteinase and angiogenesis inhibitor BAY 12-9566 in combination with 5-fluorouracil/leucovorin.
BACKGROUND: This phase I study was performed to evaluate the safety, tolerability, and efficacy of the oral matrix metalloproteinase inhibitor BAY 12-9566 in combination with 5-fluorouracil/leucovorin in patients with advanced solid tumours, and to identify the maximum tolerated dose and the dose for use in future studies. PATIENTS AND METHODS: BAY 12-9566 and 5-fluorouracil/leucovorin were administered to 17 patients in 3 cohorts. Each patient served as his/her own control, with 5-fluorouracil being given alone on days 1-5 of cycle 1. In cohort 1, BAY 12-9566 at 800 mg p.o. b.i.d. was given with 350 mg/m2 5-fluorouracil/20 mg/m2 leucovorin x 5 days q28 days. In cohort 2, the BAY 12-9566 dose was reduced to 400 mg p.o. b.i.d., with the 5-fluorouracil/leucovorin doses remaining unchanged. Finally, in cohort 3, BAY 12-9566 400 mg bid was given with 5-fluorouracil 400 mg/m2/day. Patients were continued on therapy until unacceptable toxicity or tumour progression occurred. Pharmacokinetic analyses for both BAY 12-9566 and 5-fluorouracil were performed. RESULTS: The maximum tolerated dose was 400 mg p.o. b.i.d. BAY 12-9566 plus 5-fluorouracil/leucovorin at 400 mg/m2/day and 20 mg/m2/day, respectively. Thrombocytopenia necessitated a decrease of the dose of BAY 12-9566 by 50% from cohort 1 to cohort 2. Two dose-limiting toxicities occurred in cohort 3 consisting of neutropenic fever, and ileitis, causing severe diarrhea. Of 17 patients treated on study, 7 of 14 patients evaluable for response achieved stable disease. Pharmacokinetic analysis suggested there was no interaction between BAY 12-9566 and 5-fluorouracil. CONCLUSIONS: BAY 12-9566 400 mg bid and 5-fluorouracil 350 mg/m2 plus leucovorin 20 mg/m2 can be co-administered. Although there is some evidence of a clinical interaction, there is no apparent pharmacokinetic interaction. Future studies with these 2 types of agents administered in combination are warranted.
Angiogenesis Inhibitors↗
Zonular disinsertion five years after implantation of a plate haptic silicone intraocular lens.
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Aged↗
UK national survey of prophylactic YAG iridotomy.
PURPOSE: Acute angle-closure glaucoma is a common ophthalmic emergency and individuals with shallow anterior chambers and suspected narrow angles are increasingly referred to the hospital eye service for assessment. There appears to be variation in subsequent management, with no national consensus or college guidelines. This study ascertains the current use of prophylactic YAG iridotomy in patients with no known history of an acute angle-closure glaucoma attack, and also the methods used in patient selection. MATERIALS AND METHODS: Questionnaire-based survey mailed to 650 UK consultant ophthalmologists with a covering letter in 2003. RESULTS: A total of 546 questionnaires were returned. In all, 408 respondents (74.7%) confirmed they perform prophylactic YAG iridotomy and of these 347 (85.0%) use patient symptoms and 268 (65.6%) presenting IOP in patient selection, 394 (96.6%) perform gonioscopy and 97 (23.8%) use some form of provocative test first. A total of 135 (25.3%) stated they do not perform this procedure. CONCLUSION: This study reveals current national practice among UK ophthalmologists, with variations in the assessment of patients with narrow angles but a high uptake of prophylactic YAG iridotomy.
Adolescent↗
Full-scale application of anaerobic digestion process with partial ozonation of digested sludge.
For improving sludge digestion and biogas recovery, a new anaerobic digestion process combined with ozonation was tested at a full-scale unit for 2 years and its performance was compared with a simultaneously operated conventional anaerobic digestion process. The new process requires two essential modifications, which includes ozonation for enhancing the biological degradability of sludge organics and concentrating of solids in the digester through a solid/liquid separation for extension of SRT. These modifications resulted in high VSS degradation efficiency of ca. 88%, as much as 1.3 times of methane production and more than 70% reduction in dewatered sludge cake production. Owing to accumulation of inorganic solids in the digested sludge, water content of the dewatered sludge cake also reduced from 80% to 68%. An energy analysis suggested that no supplemental fuel was necessary for the subsequent incineration of the cake from the new process scheme. The process is suitable to apply to a low-loaded anaerobic digestion tank, where power production is used.
Bacteria, Anaerobic↗
Minimization of greenhouse gas emission by application of anaerobic digestion process with biogas utilization.
To assess the impact on greenhouse gas emission, different process schemes for municipal sludge treatment were evaluated based on the data from pilot-scale experiments and review of annual operation reports. A modified anaerobic digestion process with partial ozonation of digested sludge to improve biological degradability and the conventional anaerobic digestion process were compared with respect to the energy demand in each process schemes. Options for beneficial use of biogas included (1) application of biogas for power production and (2) recovery as an alternative to natural gas utilization. The analysis indicated that the partial ozonation process with power production led to minimal greenhouse gas emission because the extra energy production from this scheme was expected to cover all of the energy demand for the plant operation. Moreover, the final amount of dewatered sludge cake was only 40% of that expected from the conventional process, this significantly minimizes the potential for greenhouse gas emission in the subsequent sludge incineration processes.
Bacteria, Anaerobic↗
Fatal renal failure as the first manifestation of sarcoidosis diagnosed on necropsy in a young man: a case report.
Renal involvement as the first manifestation of sarcoidosis is rare and has never been reported in India. This report describes a 35 year old man who was admitted to the emergency department with a clinical diagnosis of acute on chronic renal failure, secondary to obstructive uropathy. Postmortem examination unexpectedly revealed disseminated sarcoidosis.
Adult↗
Process performance and change in sludge characteristics during anaerobic digestion of sewage sludge with ozonation.
A new process configuration combining anaerobic digestion with ozonation, and operated at long SRT, was studied with the objective of on-site reduction in sludge quantity and improving biogas recovery. The process performance with respect to solid reduction efficiency and other important process parameters like accumulation of inorganic solids, changes in sludge viscosity and dewatering characteristics were evaluated from the data of long term pilot scale continuous experiments conducted using a mixture of primary and secondary municipal sewage sludge. Due to sludge ozonation and long SRT, high VSS degradation efficiency of approximately 80% was achieved at a reactor solid concentration of 6.5%. A high fraction of inorganic solid (>50%) consisting mainly of acid insoluble and iron compounds was found to accumulate in the reactor. The high inorganic content accumulated in the digested sludge did not, however, contribute to the observed increase in sludge viscosity at high solid concentration. The sludge viscosity was largely found to depend on the organic solid concentration rather than the total solid content. Moreover, higher inorganic content in the digested sludge resulted in better sludge dewaterability. For a quick assessment of the economic feasibility of the new process, an economic index based on the unit cost of digested sludge disposal to unit electric cost is proposed.
Bacteria, Anaerobic↗
Long duration priapism in blast crisis of chronic myeloid leukemia.
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Adolescent↗
Phase II study of troxacitabine (BCH-4556) in patients with advanced and/or metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada-Clinical Trials Group.
PURPOSE: A multi-institution phase II study was undertaken by National Cancer Institute of Canada-Clinical Trials Group to evaluate the efficacy and toxicity of intravenous troxacitabine (Troxatyl; Shire Pharmaceuticals Plc, Laval, Quebec, Canada), in patients with renal cell carcinoma. PATIENTS AND METHODS: Between June 1999 and March 2000, 35 patients (24 male) with a mean age of 60 years who had advanced and/or metastatic disease were treated with troxacitabine given as an intravenous infusion over 30 minutes at a dose of 10 mg/m2 intravenously, once every 3 weeks. RESULTS: Of the 33 of 35 patients evaluable for response, there were two confirmed partial responses, 21 patients had stable disease (median duration, 4.4 months), and 10 patients had progressive disease. Eight patients remained stable for more than 6 months, of whom six remain free of progression. The most common drug-related nonhematologic toxicities observed were skin rash (77.1%), hand-foot syndrome (68.6%), alopecia (51.4%), fatigue (51.4%), and nausea (57.1%). Out of a total of 145 cycles of treatment, 98 were given without steroid premedication, whereas 47 cycles were given with steroid premedication. Without premedication, skin rash occurred in 37% of cycles compared with 26% when steroids were given prophylactically. CONCLUSION: Troxacitabine given at a dose of 10 mg/m2 once every 3 weeks was well tolerated in patients with metastatic renal cell cancer, with common toxicities being a moderate to severe granulocytopenia and skin rash. Steroid premedication may reduce the frequency and severity of the skin rash. Our current study suggests that the nucleoside analog troxacitabine may have modest activity against renal cell carcinoma; however, larger studies are required to confirm this.
Aged↗
Endoscopic removal of knotted urethral catheter: a point of technique.
Urethral catheter knotting is a rare complication of the simple and widely practiced clean intermittent self-catheterization. We report the endoscopic retrieval of a retained knotted feeding tube in a 12-year-old child. Various factors leading to such a rare complication and a new minimal invasive technique are described. To the best of our knowledge this technique has not been previously reported in the medical literature.
Child↗
Anaerobic digestion of excess activated sludge with ozone pretreatment.
Source minimization of excess sludge production by economical means can be considered an attractive option to deal with the problem of sludge disposal under strict disposal standards. In this paper long-term operational results for a process that combines the oxidative ozone pretreatment with anaerobic sludge digestion are described. The ozone pretreatment solubilized around 19% and 37% of the solids at 0.015 and 0.05 gO3/gTS ozone dose. The solubilization ratios during ozonation did not show any significant difference for the sludge concentrations ranging from 1.8-2.6%. The TVS concentrations after ozone treatment were observed to be about 3% lower than the feed sludge concentrations suggesting only partial mineralization during ozonation. The ozone pretreatment resulted in improved solid reduction efficiencies during anaerobic digestion leading to higher methane recovery. The TVS removal efficiencies during anaerobic digestion were observed to increase by a maximum of 35-90% depending on the applied ozone dose during ozone pretreatment. The improvement in TVS degradation efficiency at different applied ozone doses correlated well with the extent of solubilization during ozonation. Long-term data also suggested that biomass acclimation to ozonated sludge was necessary before higher degradation efficiencies could be achieved.
Bacteria, Anaerobic↗