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Results for “Clinical study”

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At least 55 records · Page 3Linked to original sources
PubMed1978

Phase I clinical study of quelamycin.

A phase I clinical study was done with quelamycin, a recently synthesized triferric derivative of adriamycin. Twenty-one good-risk patients were studied: 19 patients with non-small cell carcinoma of the lung and two patients with metastatic sarcoma. Acute toxicity occurred in all patients and consisted of high fever, flushing, hypertension, generalized body aches, tremors, and confusion, which lasted 3-6 hours. Potentially dangerous cardiotoxicity occurred in eight patients who had previous minor rhythm disturbances, and was characterized by tachycardia, atrial extrasystoles, atrial fibrillation, and branch block which lasted 6-14 hours. The dose-limiting hematologic toxicity was found to occur at 125 mg/m2 iv single-dose. Objective responses were observed in three of 19 patients with lung cancer and in one patient with metastatic osteogenic sarcoma resistant to adriamycin therapy. In conclusion, quelamycin is a new derivative of adriamycin with potential interest. However, the acute generalized toxicity and the immediate cardiotoxicity found in the presently used schedule are excessive. Further studies directed to suppress these side effects are in progress.

Adolescent↗
PubMedDate not supplied

Initial clinical studies with bruceantin.

A phase I clinical study of bruceantin was conducted in 66 patients with various types of advanced solid tumors to evaluate its toxicity and efficacy. The initial dose of 0.2 mg/m2/day x 5 days repeated at 2-week intervals was progressively increased to a maximum dose of 4.5 mg/m2/day. Hypotension was the dose-limiting toxic effect; it was delayed, cumulative, and occurred more often in patients with abnormal pretreatment liver function. Nausea, vomiting, and fever were common at higher doses, and diarrhea, stomatitis, alopecia, paresthesia, and rash were observed in some patients. The hematologic toxicity of bruceantin was moderate at high doses and was manifested mainly as thrombocytopenia; it was more severe in patients with abnormal hepatic and renal functions. No objective tumor regressions were observed. The recommended dose of bruceantin is 3.5 mg/m2/day x 5 days for phase II studies.

Adult↗
PubMed1978

A clinical study of CAB lens wear.

A clinical study of 100 patients fit with gas permeable contact lenses (cellulose acetate butyrate) reveals a 79% success rate. The authors found good eye physiological response with minimum corneal edema, minimum corneal staining, no increase in follicular hypertrophy and minimum spectacle blur.

Adolescent↗
PubMedDate not supplied

Guanazole (NSC-1895)--a phase I clinical study.

Two dose schedules of guanazole were used in this phase I clinical study: intermittent prolonged 5-day infusion and intermittent iv bolus twice weekly. Ninety-seven treatment observations were analyzed for toxic effects resulting from the prolonged infusion and 42 from the twice-weekly bolus schedule. The main toxic effect was bone marrow suppressions, the frequency and severity of which were intensified by prior chemotherapy or radiotherapy and repetition of guanazole therapy. The leukocyte count was affected more than the platelet count. Partial responses were observed in four patients: two with lung carcinoma, one with prostate carcinoma, and one with melanoma. Further phase II clinical studies of guanazole are indicated.

Clinical Trials as Topic↗
PubMed1979

[Anti-ammonemic activity of the gamma-ethyl ester of glutamic acid. Controlled clinical study].

A controlled clinical trial was made of the anti-ammoniaemic properties of gamma-ethylester glutamic acid, arginine and placebo in a series of 45 patients with hepatic insufficiency characterized by hyperammonemia (excluding cases of pre-coma and coma) randomly assigned to three groups for treatment with: gamma-ethylester of glutamic acid (25 g), l-arginine (25 g) and physiological solution in identical 500 ml bottles. Various parameters were controlled. The results obtained were assessed with different statistical techniques, depending on the parameter concerned and the aims of the trial. Blood ammoniaemia was significantly decreased by both-ethylester of glutamic acid and arginine though the former was more effective quantitatively and in terms of time. SGOT and BSF values also followed the same pattern.

Ammonia↗
PubMed1978

[Aneurysms of the splenic artery--pathogenesis and clinical study (author's transl)].

The pathogenesis and clinical study of the aneurysms of the splenic artery will be represented from the available literature. Retrospective from the literature 144 cases were taken into consideration and a further 6 added on. The problems of the diagnosis will be discussed, the importance of the selective angiography as the only possible means for a definate pre-operative diagnosis emphasized. Different methods of operation will be described, in which the removal of the aneurysm together with a splenectomy represents the method of choice.

Adult↗
PubMed1977

[Continuous and interrupted intestinal sutures. Experimental and clinical study (author's transl)].

The authors report a clinical study of 101 cases of continuous digestive suture and an experiment comparing intestinal healing after continuous and interrupted sutures. A certain discrepancy exists between the excellent clinical results and the pathological and microscopic findings with continuous sutures, and in particular the presence of pseudo-diverticular pouches in 20% of cases developing at the expense of a mucosal evagination within the suture. If carefully performed, continuous suture seems excellent, preventing by its watertightness, the onset of early fistula.

Animals↗
PubMed1976

[Experimental and clinical study test of capreomycin].

Data on the experimental and clinical study of capreomycin in the treatment of tuberculosis are presented. It was shown that capreomycin had low activity with respect to the sensitive strain of Mycobacterium tuberculosis H37 Rv in vitro and the respective infection caused by it in mice. The activity of capreomycin in vitro with respect to streptomycin resistant strains was the same as that with respect to the sensitive strains, while in vivo it increased 3 times. Capreomycin showed a tendency to decreasing its activity with respect to strains highely resistant to canamycin only in vitro. The effect of capreomycin on tuberculosis infection caused by strains resistant to different concentrations of canamycin was the same as that on tuberculosis infection caused by sensitive strains. Cross resistance between florimycin (viomycin) and capreomycin was shown. Clinical trails of capreomycin revealed its moderate therapeutic efficiency, relatively low toxicity and an allergenizing effect on the host. Transient ventibulopatia without pronounced signs of ototoxic action was observed. The nephrotoxic effect was moderate and transient. It was observed predominantly at the peak of the allergic reactions to the antitubercle drugs. The data obtained during the study allow recommendation of capreomycin use in clinics as reserve drug when the causative agent is not resistant to florimycin. The drug should be used under regular control of the blood picture, electrolyte metabolism, state of the kidneys, auditory and vestibular apparatus.

Adult↗
PubMed1978

Congenital and acquired cytomegalovirus infections. Virological and clinical studies on a Swedish infant population.

The study included two clinical materials. First, the frequency of cytomegalovirus and its clinical significance were studied among 661 Swedish children under one year of age admitted to a paediatric hospital. Before the age of one week 4/326 (1%) children excreted virus. At one month the frequency had risen to 6/52 (12%) and after this age the frequency was constant around 20--25%. Sixty per cent of infants born to immigrants were infected after one month of age. One of the four congenitally infected children had symptoms at birth followed by neurological sequelae. The majority of the infections acquired at birth or in early infancy seemed to be subclinical and without sequelae. Second, a retrospective investigation of 18 695 children born during a six-year period was performed. Two cases of virologically confirmed congenital cytomegalic inclusion disease was found. Regarding seven microcephalic patients in the retrospective study congenital CMV-infection could be excluded in four cases. In the remaining three cases the data did not permit any conclusions regarding the etiology.

Abnormalities, Multiple↗
PubMed1979

[Clinical studies of cefamandole in children (author's transl)].

Clinical studies on cefamandole were carried out with the following results. (1) Cefamandole was administered 100 mg/kg/day (q.i.d.) by intravenous route to 29 cases of children. In 10 out of 29 cases bacteriological effect was observed. Bacteriological response was effective in 8 cases (80.0%). Clinical responses were effective in 27 cases (93.1%). (2) As to adverse reactions, granulocytopenia and elevation of S-GOT, S-GPT developed in each two cases.

Agranulocytosis↗
PubMed1978

[Prevention of recurrence of bronchial carcinomas after surgery by means of the mistletoe extract Iscador. Results of a clinical study from 1969-1971].

The results of a clinical study performed between 1969 and 1971 are reported. For prophylactic treatment against possible recurrence the mistletoe preparation Iscador was used in cases with operated cancer of the bronchial tree. The comparability of this group with a control series is tested. The Wilcoxon test in the modification of GEHAN proves a statistically significant prolongation of survival time in the Iscador group.

Bronchial Neoplasms↗
PubMedDate not supplied

Electron microscopic study of depot corticosteroid crystals with clinical studies after intra-articular injection.

Depot corticosteroid crystals and their in vivo handling after intra-articular injection have not been studied by electron microscope (EM). We therefore injected 20 mg of either prednisolone tebuate or triamcinolone hexacetonide into knee joints of 7 patients with osteoarthritis and painful effusions. Six patients had a rise in the synovial fluid leukocyte counts, but only 1 patient had clinical evidence of a post-injection flare. Scanning and transmission EM revealed intra- and extracellular crystals 24 hours and 1 week after the initial injection. These combined EM studies provide an adjunct to compensated polarized microscopy in differentiation of depot steroid from other crystals.

Adrenal Cortex Hormones↗
PubMed1975

Infantile gastroenteritis: a clinical study of reovirus-like agent infection.

In a clinical study of 32 infants with symptoms from infections with the human reovirus-like agent (R.I.A.) identified by electron microscopy (E.M.) of faecal extracts, a fairly consistent clinical pattern was found in 30 who had a gastroenteritis-like illness. The disease was usually mild, affecting mainly infants less than 2 years and males more commonly than females. The incubation period appeared to be 48-72 hours; and the onset was sudden, often with vomiting in the first 1-2 days of the illness. Loose yellow-green offensive stools without blood or mucus developed after a variable time, and there was often accompanying fever. Severe dehydration and electrolyte inbalance were uncommon; and with standard treatment the illness was uncomplicated, usually lasting 5-8 days. These features resemble those of previously reported winter epidemics of infantile non-bacterial gastroenteritis, and it is suggested that these epidemics were due to R.L.A. 2 infants in whom R.L.A. was identified in the stool did not have a gastroenteritis-like illness although both had protracted diarrhoea.

Age Factors↗
PubMed1979

[Clinical study of bacampicillin granules in pediatrics (author's transl)].

Clinical study on bacampicillin (BAPC) granules was performed in 20 children with infectious diseases. Patients treated with BAPC granules were 10 cases of scarlet fever, 3 cases of pertussis, 3 cases of Salmonella enteritis and 4 cases of acute enteritis. Clinical results were excellent in 2, good in 9, fair in 3, poor in 4 and unknown in 2. No side effect was observed.

Acute Disease↗