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Biomedical subjects

C Clary

Publications and source records attributed to C Clary.

At least 19 recordsLinked to original sources
PubMed2005

Gemcitabine-docetaxel versus cisplatin-vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin.

BACKGROUND: This multicenter, randomized, phase III study compared the efficacy, including progression-free survival (PFS), and safety of gemcitabine-docetaxel (GD) combination versus cisplatin-vinorelbine (CV) in the treatment of advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Chemonaive patients with stage IIIB or IV NSCLC were treated with GD (gemcitabine 1000 mg/m(2) days 1 and 8 plus docetaxel 85 mg/m(2) day 8, every 3 weeks for eight cycles) or CV (cisplatin 100 mg/m(2) day 1 plus vinorelbine 30 mg/m(2), days 1, 8, 15 and 22, every 4 weeks for six cycles). RESULTS: A total of 311 patients were enrolled (155 GD and 156 CV). Neither PFS nor overall survival differed significantly between the two arms (median PFS 4.2 and 4 months; median survival 11.1 and 9.6 months; 1-year survival 46% and 42%, for GD and CV, respectively). For the GD arm compared with the CV arm, the hazard ratio for PFS was 1.04 [95% confidence interval (CI) 0.83-1.32], and for overall survival, it was 0.90 (95% CI 0.70-1.16). Objective response rates did not differ significantly (31% for GD, 35.9% for CV). Myelosupression, emesis and frequency of febrile neutropenia were less pronounced on the GD arm, whereas fluid retention and pulmonary events were more pronounced. The CV arm experienced a higher number of serious adverse events and a lower compliance with the protocol. There was no quality of life (QoL) difference between arms. Median time to definite impairment of health-related QoL was 153 and 168 days in GD and CV arms, respectively. CONCLUSIONS: There was no advantage in PFS with GD compared with CV; however, the CV regimen had higher rate of toxic events, mainly myelosuppression. The herein, non-platinum-containing regimen could be considered as a rational alternative to the cisplatin-based doublet.

Adult↗
PubMed2005

Sequential two-line strategy for stage IV non-small-cell lung cancer: docetaxel-cisplatin versus vinorelbine-cisplatin followed by cross-over to single-agent docetaxel or vinorelbine at progression: final results of a randomised phase II study.

BACKGROUND: This phase II trial compared docetaxel-cisplatin (DC) with vinorelbine-cisplatin (VC), both as first-line therapy followed by cross-over at progression to single-agent vinorelbine or docetaxel in advanced non-small-cell lung cancer (NSCLC). METHODS: Overall, 115 patients received DC (docetaxel 75 mg/m(2) and cisplatin 100 mg/m(2) both on day 1, every 3 weeks, arm A1) and 118 VC (vinorelbine 30 mg/m(2)/week on days 1 and 8 and cisplatin 100 mg/m(2) on day 1, every 3 weeks, arm B1) for six cycles, and subsequently maintained by monotherapy with docetaxel (A1) or vinorelbine (B1) with cross-over on disease progression to vinorelbine 30 mg/m(2) days 1 and 8 (A2), or docetaxel 100 mg/m(2), day 1, both every 3 weeks (B2). The primary end point was overall response rate (ORR). RESULTS: Patient characteristics were balanced; median follow-up was 8.8 months. First-line response rate was 33.9% with DC and 26.3% with VC (P=0.20). In arms A1 and B1, respectively: duration of response was similar (8.2 versus 8.4 months); median time to progression was 5 months in both; median survival was 8 versus 9 months (P=0.38); 1-, 2- and 3-year survival was 36% versus 35%, 17% versus 10% and 13% versus 6% (P not significant). However, with a low number of long-term survivors, statistical significance was not reached. Overall, almost half of the patients crossed over to second-line therapy; there were no response with vinorelbine and 6 (11.2%) partial responses with docetaxel. Considering the safety profile, the occurrence of febrile neutropenia was 9.6% with DC and 26.3% with VC. Treatment-related mortality was 2.5% with DC and 8.5% with VC. CONCLUSIONS: The trend in favour of the DC arm in ORR, even though statistical significance was not reached, is consistent with previous reports. This study suggests an activity of first-line DC in advanced NSCLC, and that second-line vinorelbine does not provide additional clinical benefit. As already shown in other studies, the use of DC in first-line should provide a better percentage of long-term survivors, despite the absence of efficacy of the second-line in our study.

Adult↗
PubMed2000

Multicenter double-blind comparison of sertraline and desipramine for concurrent obsessive-compulsive and major depressive disorders.

BACKGROUND: Serotonin reuptake inhibitors (SRIs) have demonstrated consistent efficacy in the treatment of obsessive-compulsive disorder (OCD), while agents that are primarily norepinephrine reuptake inhibitors have not. Comparable efficacy has been demonstrated for SRI and non-SRI antidepressants in uncomplicated major depressive disorder (MDD). This multicenter trial is the first comparison of an SRI (sertraline) and a non-SRI antidepressant (desipramine) in the treatment of OCD with concurrent MDD. METHODS: One hundred sixty-six patients diagnosed using structured clinical interviews and recruited from 16 treatment sites were randomly assigned to double-blind treatment with either sertraline (up to 200 mg/d) or desipramine (up to 300 mg/d) over 12 weeks. Measures of severity of OCD and MDD symptoms, as well as adverse effects of the medications, were monitored over the course of the treatment period. RESULTS: Patients assigned to sertraline responded significantly better at end point on measures of OCD and MDD symptoms compared with patients assigned to desipramine. Sertraline was also associated with a significantly greater number of patients who achieved a "robust" improvement in OCD symptoms (> or =40% reduction) compared with desipramine. More patients receiving desipramine than sertraline discontinued treatment because of adverse events. CONCLUSIONS: The SRI sertraline was more effective in reducing MDD and OCD symptoms than the primarily norepinephrine reuptake inhibitor desipramine for patients with concurrent OCD and MDD.

Adrenergic Uptake Inhibitors↗
PubMed2000

Is placebo response the same as drug response in panic disorder?

OBJECTIVE: The authors used seven definitions of response in panic disorder to compare patient-rated improvements in quality of life between patients with panic disorder who responded to sertraline and those who responded to placebo. METHOD: They combined and examined data from two multicenter, randomized, double-blind, parallel-group, flexible-dose studies of panic disorder (N=302). RESULTS: Significant differences in quality of life between patients who responded to sertraline and those who responded to placebo were apparent across all the definitions of clinical response. CONCLUSIONS: Patients who respond to placebo in panic disorder treatment studies may show symptom relief but may not experience improvement in quality of life. Determinations of quality of life should be included as components of both standard clinical assessment and clinical treatment studies of patients with panic disorder.

Attitude to Health↗
PubMed1994

Nefazodone and imipramine in major depression: a placebo-controlled trial.

Nefazodone is a phenylpiperazine antidepressant with 5-HT2 antagonism and 5-HT reuptake inhibition. Two hundred and eighty-three out-patients with a diagnosis of DSM-III-R major depression of at least one-month duration (65% ill for over 6 months), and a mean score of 24 on the 17-item Hamilton Rating Scale for Depression (HRSD), were randomised to treatment with nefazodone, imipramine, or placebo. The double-blind treatment period was 8 weeks in duration. Nefazodone's antidepressant efficacy was comparable with imipramine's, with both drug treatments significantly better than placebo in a variety of outcome measures. For example, after 8 weeks of therapy, 78% of nefazodone and 83% of imipramine but only 55% of placebo patients (P < 0.01) were globally much or very much improved. Nefazodone was better tolerated than imipramine, with fewer drop-outs and a lower incidence of side-effects during treatment.

Adult↗
PubMed1992

Psychiatric inpatients' knowledge of medication at hospital discharge.

Results of a survey of 253 psychiatric inpatients on the day of discharge from a short-stay hospitalization indicated that more than half did not know the name and dosage of the psychiatric medications prescribed for them and why they were taking them, even though they had received both group and individual medication instruction during hospitalization. Sixty-eight percent of the patients knew the names of all their psychiatric medications, but only 53 percent knew when to take them. Sixty-three percent felt that they had some understanding of why the medications were prescribed, while 37 percent said they did not know. Younger, better-educated patients who had an affective illness (as opposed to schizophrenia) were more likely to have adequate knowledge of their medication regimen. Results suggest the need for more active forms of medication education, such as supervised self-administration in the final days of hospitalization.

Adolescent↗
PubMed1992

The efficacy and safety of paroxetine compared with placebo in outpatients with major depression.

Paroxetine, a phenylpiperidine derivative, is an antidepressant that selectively inhibits serotonin reuptake. In this study 111 outpatients with major depression diagnosed by DSM-III criteria were treated with either paroxetine or placebo in a 6-week, randomized, double-blind study. Paroxetine was significantly superior to placebo on six of the seven major efficacy variables. Significant differences in favor of paroxetine were apparent by Week 2. Paroxetine was also well tolerated. These results support the efficacy and safety of paroxetine as a treatment for patients with major depression.

Adult↗
PubMed1992

The use of low-dose intranasal midazolam to treat panic disorder: a pilot study.

BACKGROUND: Drug therapy of panic disorder, despite the intermittent nature of the panic attack, requires daily administration of antidepressants, which are often not tolerated, or benzodiazepines, which can result in physical dependence and withdrawal. The use of rapidly acting, low-dose intranasal midazolam to prevent incipient panic suggested itself to us as a novel alternative treatment strategy. METHOD: We conducted a 6-week double-blind, placebo-controlled, crossover-design pilot study of the safety and efficacy of p.r.n. low-dose intranasal midazolam in five patients diagnosed with DSM-III-R panic disorder. RESULTS: One to two drops of midazolam (approximately 0.25 to 0.5 mg) was well tolerated and highly effective in preventing incipient panic attacks and in reducing the overall weekly frequency of attacks. CONCLUSION: Intermittent intranasal midazolam shows promise as a novel alternative treatment for panic, but a controlled study of its efficacy and safety (including abuse potential) must be conducted.

Administration, Intranasal↗
PubMed1991

Hyaluronan and a cell-associated hyaluronan binding protein regulate the locomotion of ras-transformed cells.

Hyaluronan (HA) and one of its cell binding sites, fibroblast hyaluronan binding protein (HABP), is shown to contribute to the regulation of 10T1/2 cell locomotion that contain an EJ-ras-metallothionein (MT-1) hybrid gene. Promotion of the ras-hybrid gene with zinc sulfate acutely stimulates, by 6-10-fold, cell locomotion. After 10 h, locomotion drops to two- to threefold above that of uninduced cells. Several observations indicate increased locomotion is partly regulated by HA. These include the ability of a peptide that specifically binds HA (HABR) to reduce locomotion, the ability of HA (0.001-0.1 micrograms/ml), added at 10-30 h after induction to stimulate locomotion back to the original, acute rate, and the ability of an mAb specific to a 56-kD fibroblast HABP to block locomotion. Further, both HA and HABP products are regulated by induction of the ras gene. The effect of exogenous HA is blocked by HABR, is dose-dependent and specific in that chondroitin sulfate or heparan have no significant effect. Stimulatory activity is retained by purified HA and lost upon digestion with Streptomyces hyaluronidase indicating that the activity of HA resides in its glycosaminoglycan chain. Uninduced cells are not affected by HA, HABR, or mAb and production of HA or HABP is not altered during the experimental period. These results suggest that ras-transformation activates an HA/HABP locomotory mechanism that forms part of an autocrine motility mechanism. Reliance of induced cells on HA/HABP for locomotion is transient and specific to the induced state.

Carrier Proteins↗
PubMed1991

Placebo-controlled trial of venlafaxine for the treatment of major depression.

Results are presented of the first double-blind, placebo-controlled trial of a novel antidepressant venlafaxine, which preclinically has demonstrated serotonin, norepinephrine, and dopamine reuptake inhibiting effects. Sixty outpatients meeting DSM-III-R criteria for major depression were randomized to receive 6 weeks of treatment with one of three fixed doses of venlafaxine--25 mg three times a day, 75 mg three times a day, or 125 mg three times a day--or placebo. Significant improvement was observed in depression scores at all doses, with the high dose resulting in earlier improvement, by week 2. For the combined venlafaxine treatment groups, 68% achieved a moderate or marked improvement on the Clinical Global Impression scale, compared with only 31% for the placebo group. Venlafaxine was well tolerated, and nervousness, sweating, and nausea were the only adverse effects observed more frequently with drug compared with placebo.

Adult↗
PubMed1991

Buspirone in major depression: a controlled study.

One hundred and fifty-five outpatients suffering from major depression with moderate anxiety entered a double-blind study comparing 8 weeks of treatment with buspirone or placebo. Thirty-four percent of buspirone and 41% of placebo patients discontinued treatment before 8 weeks. Results were consistent across all physician- and patient-completed outcome measures, with treatment response to buspirone significantly better than to placebo at treatment endpoint. Seventy percent of buspirone and 35% of placebo patients (p less than .01) were rated moderately or markedly improved after 8 weeks of therapy. Initial levels of anxiety and depression had no significant effect on treatment outcome. Buspirone was found to be safe and well tolerated at doses of up to 90 mg/day.

Adolescent↗
PubMed1990

Buspirone in depressed outpatients: a controlled study.

One hundred fifty-five outpatients suffering from major depression with significant anxiety entered a double-blind study comparing 8 weeks of treatment with buspirone or placebo. Twenty-nine percent of buspirone and 40 percent of placebo patients discontinued treatment before 8 weeks. Major efficacy measures were the Hamilton Rating Scale for Depression (HAM-D) total score, the HAM-D retardation and anxiety factors, the HAM-D Rickels and Bech core depression clusters, the Clinical Global Impressions (CGI), and the Hopkins Symptom Checklist (HSCL). Results were consistent across all outcome measures, including the two core depression clusters, with treatment response to buspirone significantly better than to placebo at treatment endpoint. Seventy percent of buspirone and 35 percent of placebo patients (p less than .01) were rated moderately or markedly improved after 8 weeks of therapy. Buspirone was found to be safe and well-tolerated by patients with major depression and concomitant anxiety at doses of up to 90 mg/day.

Anxiety Disorders↗
PubMed1990

Results of a brief survey on the prescribing practices for monoamine oxidase inhibitor antidepressants.

Four hundred eighty-five psychiatrists in Pennsylvania and Delaware responded to a survey of prescribing practices for the monoamine oxidase inhibitor (MAOI) antidepressants. Although the low response rate (34%) limited the generalizability of the results, the similarity between respondents and the total sample surveyed argued against gross sampling bias. The authors found that only a minority of psychiatrists (25%) prescribe MAOIs regularly, despite a relatively low rate of reports of serious sequelae from hypertensive crises or other side effects. They also found that a substantial number of psychiatrists who regularly prescribe MAOIs also report prescribing high doses and combining therapy with tricyclics, lithium, neuroleptics, and psychostimulants. These findings have implications for postmarketing research on psychotropic drugs.

Anxiety Disorders↗
PubMed1989

A placebo-controlled, double-blind, clinical trial of paroxetine in depressed outpatients.

A placebo-controlled, randomized, double-blind study was carried out in outpatients suffering from major unipolar depressive disorder to assess the efficacy and tolerability of paroxetine in the treatment of depression. The study lasted for six weeks. After a placebo washout period of 4 to 14 days patients took 20mg of paroxetine or matched placebo as a morning dose for one week; thereafter the dose of paroxetine could be titrated between 10 and 50mg/day. Patients were evaluated at baseline, weekly during the first four weeks of the study, and at the end of six weeks; patients who entered a six-week extension phase were evaluated at 9 and 12 weeks. Evaluations were carried out using HAMD (including ECDEU factors), MADRS, HSCL, Covi anxiety and Raskin depression scales, CGI, and a seven-point rating of global improvement. Adverse events and laboratory values were also recorded at each assessment. One hundred and eleven patients entered the study, and efficacy data were available for 102 of these (49 on paroxetine and 53 on placebo). Efficacy measurements demonstrated significantly greater clinical improvement with paroxetine than placebo after two weeks of treatment, and this became even more marked after six weeks. Patients who continued treatment for a further six weeks maintained their clinical improvement. When adverse events were examined, statistically significant differences between paroxetine and placebo were seen only for sweating, diarrhoea, nausea, and somnolence. No significant changes were seen in any of the laboratory parameters measured. If these results are confirmed in future studies, paroxetine will represent an important addition to the treatments available for depression.

Adult↗
PubMed1988

Treatment of brain metastases of lung cancer with high doses of etoposide (VP16-213). Cooperative study from the Groupe Franais Pneumo-Cancérologie.

To study the efficacy of etoposide in brain metastases of lung carcinoma, etoposide was given during 3 consecutive days. The total dose of 1500 mg/m2 was divided into six 1 h perfusions delivered over 3 days to 19 patients having squamous (7), large cell (3), small cell (5) or adenocarcinoma (4). Response to chemotherapy was assessed by means of computerized tomography (CT) before and 15-30 days after the last course of chemotherapy (course interval = 28 days, maximum of four courses). Severe myelotoxicity was observed in nine patients with seven patient deaths resulting from infection. Efficacy could be evaluated in 13 patients. Failure was observed in seven cases. An objective response was observed in six patients (4/14 NSCLC and 2/5 SCLC), two patients having a complete regression. Average survival time was 10 weeks.

Adenocarcinoma↗
PubMed1988

Suicide upon recovery from depression. A clinical note.

We present two cases of suicide upon recovery from severe depression. In both cases a hypomanic phase followed by a switch down into depression appeared to be the clinical context of the impulsive suicidal act. We offer a critique of the hypothesis that accounts for suicidality during early remission from depression in terms of "mobilization of energy."

Adult↗