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Biomedical subjects

G Giani

Publications and source records attributed to G Giani.

At least 55 records · Page 3Linked to original sources
PubMed1996

A randomized multicenter trial of adjuvant therapy in superficial bladder cancer: transurethral resection only versus transurethral resection plus mitomycin C versus transurethral resection plus bacillus Calmette-Guerin. Participating Clinics.

PURPOSE: A randomized multicenter trial was done to compare transurethral resection only to transurethral resection plus adjuvant mitomycin C and bacillus Calmette Guerin (BCG) instillation for treatment of superficial bladder cancer (stage pTa/1 grades 1 to 3 except primary stage pTa grade 1). MATERIALS AND METHODS: Included in the study were 337 patients with superficial stage pTa/1 grades 1 to 3 bladder cancer except primary stage pTa grade 1 tumors. One group underwent transurethral resection alone. Mitomycin C (20 mg./50 ml. sodium chloride) was given every 2 weeks during year 1 and once a month during year 2. BCG (120 mg/50 ml. sodium chloride was instilled once a week for 6 weeks and once a month for 4 months. RESULTS: At a median followup of 20.2 months, a decrease in recurrence rate was noted for both drug instillations compared to transurethral resection only. The relative risk of recurrence was 0.508 after mitomycin C and 0.618 after BCG instillation compared to transurethral resection alone. There was no significant difference between the mitomycin C and BCG instillations. The progression rate was comparable in all 3 therapy groups, with an estimated common progression rate of 4.22% per year. Side effects occurred most frequently during or after BCG instillation, most often consisting of cystitis. One patient required cystectomy because of ulcerating cystitis and a prostatic abscess subsequent to unsuccessful tuberculostatic therapy. There were no systemic complications. CONCLUSIONS: Our study showed a positive effect of adjuvant chemotherapy and immunotherapy on decreasing tumor recurrence rate. No influence was observed concerning progression rate, which was low overall.

Adjuvants, Immunologic↗
PubMed1996

Diabetes as a predictor of mortality in a cohort of blind subjects.

BACKGROUND: There is only a little information about survival in newly registered blind subjects. METHODS: A closed cohort of blind subjects (n = 2680, 1803 of them women), newly registered between 1990 and 1993 in the district of Württemberg-Hohenzollern, Germany, was observed for up to 48 months. Mortality was compared to that of the general population. Predictors of mortality within that cohort were identified by Cox proportional hazards regression analysis. RESULTS: Before 1 February 1994, 582 of the subjects had died. Diabetes had been diagnosed in 772 of the subjects, 226 of them died. The overall incidence rate of death was 12179 per 100,000 per year. The probability of survival after 47 months was 0.64 (95% confidence interval (CI): 0.59-0.70) in the non-diabetic, and 0.46 (95% CI: 0.37-0.55) in the diabetic subjects. Predictors of mortality in the regression model were age (risk ratio [RR] per year of age 1.047), sex (RR for men 1.247) and diabetes (RR when blindness was unrelated to diabetes: 1,448, RR when diabetes was the only cause of blindness: 2,253). Compared with the entire population, mortality was considerably increased in the blind cohort (comparative mortality figure [CMF] 4.79), particularly in individuals with diabetes (CMF = 6.55). The relative risks decreased with increasing age. CONCLUSIONS: Overall mortality in this cohort was high, even higher than in previous studies on the mortality of the blind. Diabetes increased the risk of death. In addition, the cause of blindness in diabetic individuals was a major predictor of mortality.

Adolescent↗
PubMed1996

Incidence of lower limb amputations and diabetes.

OBJECTIVE: We collected data on the incidence rates of amputations and their relative risk in diabetic subjects compared with the nondiabetic population. RESEARCH DESIGN AND METHODS: From all three hospitals in a city of approximately 160,000 inhabitants, we obtained complete lists of nontraumatic lower limb amputations. From each patient record, diabetic status was determined. We estimated age-specific and standardized incidence rates of amputations in the diabetic and nondiabetic populations and in the entire population, as well as the relative and attributable risks due to diabetes. RESULTS: Nontraumatic lower limb amputations were performed on 106 residents of Leverkusen (Germany) in 1990 and 1991. Of them, 82 (77.4%) had diabetes. Mean age was 72.0 years. In the case of multiple amputations, only the highest level was counted for the analysis. The following results were standardized to the German population. Incidence rates (100,000(-1) year-1) were determined to be as follows: for all amputations per total population, 33.8; for amputations in diabetic individuals per diabetic population, 209.2; for amputations in nondiabetic individuals per nondiabetic population, 9.4. Relative risk was 22.2; attributable risk among exposed, 0.96; population attributable risk, 0.72. When the study is repeated to monitor the St. Vincent targets (50% reduction), a reduction in the amputation rate in the diabetic population by 46% will be detected with 90% power. CONCLUSIONS: We found incidence rates similar to those in the non-Indian population of the U.S. Great relative and population-attributable risks indicate that improving foot care in diabetic individuals appears to be the main target for the reduction of amputations in the general population.

Adult↗
PubMed1993

On the sequential design of the Deutsche Nikotinamid Interventionsstudie--DENIS.

The "Deutsche Nikotinamid Interventionsstudie" (DENIS) is a sequentially designed double blind clinical trial. This paper describes the design and monitoring of the trial. In contrast to the classic fixed-sample design the chosen sequential triangular test allows the trial to be terminated and the final result to be concluded, keeping the predetermined error probabilities of the test after an interim analysis. The main reason for this sequential test was the desire for early results because of the expected large diabetes risk reduction on the one hand and the risk of side effects on the other. Furthermore, all probands of the trial may change therapy and thus also potentially benefit from an earlier outcome of the study. The trial is designed in such a way that, assuming a 3 year diabetes incidence of 30% in the placebo group, a reduction to 6% in the nicotinamide group can be ascertained with a power of 90% using a significance level of 5%. This results in the following monitoring procedure: Probands are randomly assigned to the placebo or the nicotinamide group until termination of the study or reaching a sample size of 130. Interim analyses are performed whenever 5 new diabetic cases are manifested but at the earliest after 18 months. At each interim analysis it is decided whether to continue or to end the trial. A final result will be reached at the latest after the occurrence of 22 diabetes manifestations. But as shown, probably less than 16 diabetes manifestations will be needed, which is the number required using a fixed sample design.(ABSTRACT TRUNCATED AT 250 WORDS)

Child↗
PubMed1991

How reliable are short-term measurements of oxygen uptake in polytraumatized and long-term ventilated patients?

O2-uptake was measured continuously in 18 polytraumatized and 21 long-term ventilated patients. All patients were on assisted ventilation with sufficient sedation and analgesia. O2-uptake was measured every minute, the values were recorded over 24 h and the mean O2-uptake/min was calculated. At the same time, the O2-uptake of the last 15 min of every hour was measured separately (e.g. 7.45-8.00, 8.45-9.00, etc.). The mean O2-uptake/min measured continuously was compared and correlated with the mean O2-uptake per day, calculated on the basis of each of the short-term measurements. There were only slight differences between the mean values of the two procedures: In the group of long-term ventilated patients the mean O2-uptake was found to be 364 ml/min in continuous measurements and 363 ml/min in short-term measurements. This O2-uptake corresponded to an energy expenditure of 2360 kcal/day. The mean correlation coefficient was 0.89 (range: 0.79-0.96). If O2-uptake was measured over 2 periods of 15 min each, e.g. in the late morning and in the afternoon, the mean correlation coefficient improved to 0.94 and the standard deviation was reduced. Comparable results were obtained in the group of polytraumatized patients. This study shows that under certain preconditions short-term measurements of O2-uptake of 2 x 15 min allow sufficiently reliable predictions of the daily O2-uptake and energy expenditure in severely traumatized or critically ill patients.

Adult↗
PubMed1990

[The effect of various factors on the progression of kidney insufficiency cause by analgesic nephropathy].

In a retrospective study of 33 patients the influence of different anamnestic, clinical and laboratory parameters on the progression of renal failure was investigated. The analysis of progression of renal failure was evaluated in terms of a reasonable criterium intuitively suggesting itself which is based on a non-linear fitting of the serum creatinine profile. Follow-up serum creatinine levels showed that renal function became worse in 28 cases, with terminal renal failure developing in 6 cases. In 5 patients significant improvement in kidney function was observed. The variables systolic and diastolic blood pressure, total amount of ingested analgesics, continued abuse and cessation of analgesics, frequency of urinary tract infections and amount of proteinuria had no significant influence on progression of renal failure. However, a strong relationship between the initial serum creatinine level and the progression of renal failure could be established. In conclusion our results indicate that long-term prognosis of analgesic nephropathy mainly depends on early diagnosis.

Adult↗
PubMed1990

The influence of posttraumatic parenteral calorie and nitrogen supply upon the cumulative nitrogen balance.

The aim of the study was to describe the influence of posttraumatic calorie and nitrogen (N) supply upon the cumulative N-balance by analyzing the literature of the past 18 years. Three groups of patients were formed, in which nutritional therapy was performed following trauma of differing severity: (1) patients following moderate trauma-N-losses 10-15 g/day; (2) patients following severe trauma--N-losses 15-20 g/day; and (3) polytraumatised patients--N-losses more than 20 g/day. The data gained for the calorie and N-supplies as well as for the N-balances in each group of patients served as a basis for the calculation of regression analyses of higher order; in these the cumulative N-balance was regarded as a function of the calorie and the N-supply: NBcum = f (C, N) Whilst for the group of polytraumatized patients only statements for a nutrient supply of about 20-30 kcal/kg BW/day and 0.2-0.3 g N/kg BW/day are possible, due to the limited data available, general statements about the different influence of calorie and N-supply can be made for nutritional therapy after moderate and major trauma; the calculated functions reveal that the N-supply influences the N-balance decisively, whereas the calorie supply exerts only a slight N-sparing effect. The mathematically calculated optimum of the N-supply after severe trauma is 0.2 g/kg BW/day, corresponding to an amino acid supply of 1.25 g/kg BW/day.

Algorithms↗
PubMed1990

Adjuvant systemic chemotherapy after complete transurethral resection of superficially invasive bladder carcinoma (T1 G3-4 and T2 G2-4).

A prospective multicenter phase-two study was initiated in 1983 to evaluate the effect of systemic chemotherapy after complete resection of T1 G3-4 and T2 bladder carcinomas. Chemotherapy consisted of three cycles of cisplatin alone, a modified MVAC scheme or the combination of cisplatin and methotrexate. 52 patients entered the study. After a medium follow-up of 36 months 11 patients developed progression of the disease; cystectomy had been performed in 8 patients and 6 patients died due to progressive bladder carcinoma. These encouraging results should be the base for a randomized trial with the aim to improve survival and avoid cystectomy in selected patients with superficially invasive bladder cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

Free perforation due to colonic adenocarcinoma in Crohn's disease.

Free perforation of the bowel due to cancer in Crohn's disease is very rare. One case found among 75 cases of Crohn's disease is reported. The perforation occurred in a mucinous adenocarcinoma of the ascending colon in a 54-year-old woman with a 17-year history of Crohn's disease, who had undergone two previous operations of small bowel and colonic resection. A right hemicolectomy was performed; the patient had an uneventful recovery and does not show recurrence of cancer at 31-month follow-up. This is in contrast with a recent review, in which a very poor prognosis was claimed for the perforated colonic cancer in Crohn's disease.

Adenocarcinoma, Mucinous↗
PubMed1988

Natural history and treatment of low and high risk superficial bladder tumors.

Since 1979 a prospective randomized trial was done to examine the efficacy of intravesical doxorubicin as prophylaxis against recurrence. After complete transurethral resection of the tumor, patients were divided into 3 groups at random: group 1-no further treatment after transurethral resection, group 2-doxorubicin twice weekly for 6 weeks and group 3-doxorubicin for 1 year. A total of 268 patients entered the study. Neither frequency of recurrences, tumor progression nor survival rate was improved significantly by the adjuvant treatment, so that only a limited number of patients will profit by instillation therapy. Analysis of previously reported data suggests that patients with superficial bladder tumors can be stratified into groups with appreciable differences in risk of progression. With regard to these results a differentiated use of a "wait and see" adjuvant intravesical therapy and more aggressive treatment after transurethral resection of superficial bladder tumors seems to be indicated rather than a general practice of chemoprophylaxis.

Administration, Intravesical↗
PubMed1988

Glucose, fructose, and xylitol in postoperative hypocaloric parenteral nutrition.

The aim of the study was to use glucose, fructose and xylitol as alternative carbohydrates in hypocaloric parenteral nutrition (HPN) and to investigate their different nutritional effects. Twenty-four patients who had undergone elective gastrointestinal resection were examined in a prospective randomized study. Only metabolically normal patients between 30 and 65 years of age were admitted to the study. No patient with a body weight more than 20% above or below the normal weight of the patients was admitted. The study period extended from the operation day to the fifth postoperative day. The patients were given approximately 1.1 g amino acids and approximately 2.9 g carbohydrates per kg/B.W. and day using either glucose, fructose or xylitol as carbohydrates. The mean plasma glucose concentrations ranged between 6 and 8 mmol/l without insulin being supplied. There were no significant differences between the groups. However, the administration of glucose led to a somewhat larger dispersion range of the values. The labile plasma proteins (transferrin, prealbumin, retinol-binding protein) in the 3 groups revealed almost identical concentration courses. With N-losses between 51 and 57 g/4 days, only slightly negative cumulative N-balances were calculated (-4 to -13 g/4 days). No significant differences were observed between the 3 groups in the level of the urea-N production rates. Advantages which favor a general administration of fructose/sorbitol or xylitol in HPN could not be found in our investigation.

Adult↗
PubMed1987

Continuous measurement of oxygen uptake. Evaluation of the Engström metabolic computer and clinical experiences.

A new system for continuous measurement of oxygen uptake was tested. The tidal volumes delivered by the system, the accuracy of the oxygen sensor cell, measurement of the oxygen uptake at different inspired oxygen concentrations, and comparative tests of oxygen uptake using the Fick principle were studied. Judging from our results, even thorough maintenance could not entirely prevent leakages. Due to a construction error, there was a large increase in measured oxygen uptake if inspired oxygen concentration was increased. While carbon-dioxide output was constant, this led to respiratory quotients of less than 0.5. By modifying the system with a mixing chamber for the inspiratory gas, new tubing to the oxygen sensor cell and changes in the computer software, these errors have been corrected in the meantime. In comparative tests of oxygen uptake using the Fick principle (cardiac output and arteriovenous oxygen content difference), we found a mean difference between EMC and the Fick principle of about 6.6% (P less than or equal to 0.001, r = 0.91) with nearly identical standard deviations for both values. Our experience indicates that the EMC is suitable for continuous measurements of oxygen uptake. Additional technical improvements seem to be possible.

Anesthesiology↗
PubMed1987

[Painless extra-corporal shock wave lithotripsy using the HM3 Dornier lithotripter].

In a clinical study with a modified shock wave generator supplied by Dornier Medizintechnik for the Dornier Kidney Lithotripter HM3 the requirement of analgetics decreased significantly during Opioid-Analgesia. It could be shown that Extra-corporal Shock Wave Lithotripsy is possible without a central acting drug. Furthermore, a reduction of perioperative morbidity could be observed with the new generator.

Analgesia↗
PubMed1986

[Various staining procedures in exfoliative urine cytology. Use in routine urology].

Exfoliative urinary cytology should be included in the diagnostics and follow up of bladder carcinomas. Staining according to Papanicolaou is time consuming and expensive. Therefore the accuracy of cytology after methylene blue staining, use of prestained slides and Papanicolaou staining was investigated. Urine and bladder washouts were taken from 77 patients with histologically proven bladder tumors, 152 patients after resection of the tumor and 100 patients without tumor of the urinary tract. The results show comparable accuracy of the different staining techniques. Methylene-blue stained and prestained slides cannot be used for documentation; therefore all specimens, which show tumor or are suspicious should also be stained according to Papanicolaou.

Cystoscopy↗
PubMed1985

[Continuous measurement of oxygen uptake using the Engström Metabolic Computer].

A new system for continuous measurement of oxygen uptake was tested (EMC). Delivered tidal volumes of the system, the accuracy of the oxygen sensor cell, measurement of the oxygen uptake related to different inspiratory oxygen concentrations as well as comparative tests of oxygen uptake according to Fick's principle were studied. Furthermore, we looked for possible leakages in the system. Following to our results even thorough maintenance could not entirely prevent leakages. There was a remarkable increase in measured oxygen uptake if inspiratory oxygen concentration was increased. While carbon-dioxide output was measured at constant levels this led to low respiratory quotients, some of these were less than 0.5. This was caused by a construction error of the system which could be corrected in the meantime. In 70 comparative tests of oxygen uptake between EMC and Fick's principle (measurement of cardiac output and arteriovenous oxygen content difference) we found a mean difference of about 10% (p less than or equal to 0.001) with nearly identical standard deviations. The EMC measured the higher oxygen uptake. Based on our experience the EMC is suitable for continuous measurement of oxygen uptake but it needs good knowledge of the system and the underlying measuring procedures. Additional technical improvements seem to be possible.

Adolescent↗
PubMed1984

[Parenteral feeding following heart surgery operations].

After aorto-coronary bypass operations 40 patients were treated in a prospective-randomized study with 3 types of hypocaloric parenteral nutrition consisting of the same content of amino acids (75 g/day) but different amounts of carbohydrates: 120 g dextrose, 120 g or 200 g dextrose/fructose/xylitol (1:2:1) per day. 18 patients received only 75 g/day of dextrose (controls). The fluid volume for parenteral nutrition did not exceed 1500 ml/day. Changes in carbohydrate and protein metabolism were investigated. Because of restricted carbohydrate dosage, we needed no insulin to keep blood glucose within values of about 7-10 mmol/l. Postoperative serum insulin levels were significantly raised to 4-5 fold of preoperative values in all groups. Serum potassium concentrations remained normal under a supply of 80-100 mmol/day. Cumulative nitrogen balances were improved by about 48-58% in groups receiving parenteral nutrition despite a calorie/nitrogen ratio of 40:1 or 66:1 respectively. The expected beneficial effects on the concentrations of visceral serum proteins (transferrin, prealbumin, retinolbinding protein, cholinesterases) could not be found.

Blood Glucose↗