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Results for “Clinical Trials as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 19 recordsLinked to original sources
PubMed1975

Povidone-iodine for the control of surgical wound infection: a controlled clinical trial against topical cephaloridine.

One hundred and ninety-two operation wounds ina general surgical practice were randomly allocated to receive either topical cephaloridine or a providone-iodine spray, and the rate of wound sepsis was studied. In all types of operation cephaloridine proved superior to providone-iodine as a prophylactic, the difference reaching a significant level in potentially contaminated wounds.

Administration, Topical↗
PubMed1976

Clinical trials of topical interferon therapy of ulcerative viral keratitis.

An open trial suggested that monkey interferon had a therapeutic effect on ulcerative vaccinial keratitis in humans. A randomized, double-blind, placebo-controlled trial of either monkey interferon or drops of idoxuridine (given hourly by day and at 2-hr intervals by night for three days) suggested a therapeutic effect from idoxuridine but not from monkey interferon. Results of experiments with rabbits suggested that a daily application of human interferon (1.1 X 10(7) international units/ml) would be effective in the prevention of herpetic ulcers but might not affect established lesions. Preliminary results are encouraging in a placebo-controlled, randomized trial of human interferon given once daily for seven days for prevention of recrudescence of epithelial herpetic lesions after minimal wiping debridement with a cotton-tipped swab. The design of the trial is closely analogous to that of the experiments with rabbits and permits ethically acceptable, placebo-controlled trials of antiviral agents.

Administration, Topical↗
PubMed2026

Descemet Stripping Only in Fuchs Endothelial Corneal Dystrophy: Results of a Randomized Clinical Trial of Topical Ripasudil and Directions for Future Innovation.

PURPOSE: To review history of Descemet stripping only (DSO) in Fuchs endothelial corneal dystrophy, describe the results of a clinical trial of topical ripasudil after DSO (K-321-201 study), and discuss future directions. METHODS: A 1-year, phase 2, randomized, placebo-controlled multicenter clinical trial of two doses of K-321 (ripasudil) administered for 12 weeks after DSO surgery in Fuchs endothelial corneal dystrophy was performed. The primary endpoint, central corneal endothelial cell density (ECD) at 12 weeks after surgery, was determined by an independent reading center that was masked to study group assignment. Duration of corneal edema, need for medical or surgical rescue therapy, corneal thickness, and central ECD throughout the entire study period were also examined. Adverse events and exploratory endpoints were collected. RESULTS: Sixty-five subjects were enrolled (21 in the QID group, 22 in the BID, and in the placebo group). Over 95% of subjects completed the trial. The QID group had a higher central ECD 12 weeks after DSO than the placebo group (531 &#xb1; 312 cells/mm2 vs 228 &#xb1; 298 cells/mm2, P = .0065). Corneal edema cleared in 17/21 (81.0%) of the QID group at 12 weeks, compared with 2/22 (9.1%) of the placebo group (P < .0001). Rescue was required in 2/21 (9.5%) subjects in the QID group and 6/22 (27.3%) subjects in the placebo group (P = .0092). Adverse events were mild and did not lead to discontinuation of treatment. CONCLUSIONS: Topical K-321 given QID improves DSO outcomes, as demonstrated by a higher ECD, more rapid resolution of corneal edema, and reduced failure rate. The medication was well-tolerated.

Humans↗
PubMed1979

Double-blind clinical trial of topical steroids in anterior uveitis.

We present the results of a double-blind trial comparing the efficacy of betamethasone phosphate 0.1%, clobetasone butyrate 0.1%, and placebo in the treatment of acute unilateral nongranulomatous uveitis. The 2 steroids were equally comparable in improvement of the patients' symptoms, though betamethasone phosphate was significantly more effective than clobetasone butyrate in improving the ocular signs of uveitis. However, clobetasone butyrate had significantly less effect on raising intraocular pressure in known steroid responders and ocular hypertensives than did dexamethasone. The use of a bolometer as an objective measure in uveitis was significant only in the more severe cases of uveitis. In comparing the placebo group of patients with those on topical steroids, the former group, though improving, appeared to lag behind by approximately one week. Four cases on placebo, however, had to be withdrawn because of worsening of the condition. Mild cases of anterior uveitis would probably resolve without using topical steroids.

Administration, Topical↗
PubMed1979

Influence of the base on the results of clinical trials with topical corticosteroids.

A comparative trial between betamethasone valerate and halcinonide has shown the former to be superior, thus contradicting the results from other trials. It is thought that the discrepancy is due to differences in the nature of the preparations used in the various studies. It is suggested that note is made of the base used in trials before final conclusions about the efficicacy of steroids are made.

Administration, Topical↗
PubMed1979

A clinical trial of topically applied 3 percent vidarabine against recurrent herpes labialis.

Seventy-six participants were enrolled in a clinical trial to determine therapeutic effectiveness of 3 percent vidarabine applied topically to recurrent perioral herpetic lesions. Following a 6- to- 12-month natural history phase, a 12-month clinical trial was conducted. Seventy participants developed 463 lesions during 361 episodes. Three percent vidarabine in a water-miscible gel was applied six times daily for 7 days to each lesion in the experimental group. Identically packaged placebo was used by the control group. Group assignment was by computer-generated randomization. Lesion size was reduced when vidarabine, rather than placebo, was applied. The difference was statistically significant (Student's t test, P = 0.02). Vesiculation followed tingling more rapidly when vidarabine, rather than placebo, was applied prior to vesiculation (P = 0.05). No significant difference between the two groups was found in episode frequency or lesion duration. Adverse reactions to vidarabine were not experienced.

Administration, Topical↗
PubMed1978

Clinical trial of topical disodium chromoglycate in vernal keratoconjunctivitis.

The clinical picture of Spring catarrh was studied in 96 cases. The duration of the disease was found to be 3.5 +/- 2.6 years. It exists all the year round with a higher frequency between April and August. Male children were affected about three times more frequently than females. The effect of DSCG was studied in 20 cases. It had a significant therapeutic effect. We advise a combined DSCG and corticosteroid treatment in the period of exacerbation.

Administration, Topical↗
PubMed1976

Corticosteroid therapy for the reduction of postoperative inflammation after cataract extraction.

In an random, double-masked multicentric clinical trial, topical betamethasone phosphate 0.1% or placebo eyedrops were used five times daily for the first two weeks after uncomplicated intracapsular cataract extraction in 107 patients who had moderate to severe postoperative inflammation on the first postoperative day. Topical corticosteroid solution was significantly more effective than placebo in the reduction of postoperative ocular inflammation. There were no ocular complications of corticosteroid treatment.

Adrenal Cortex Hormones↗
PubMed1979

Allocation of patients to treatment in clinical trials.

This article is intended as a practical guide to the various methods of patient assignment in clinical trials. Topics discussed include a critical appraisal of non-randomized studies, methods of restricted randomization such as random permuted blocks and the biased coin technique, the extent to which stratification is necessary and the methods available, the possible benefits of randomization with a greater proportion of patients on a new treatment, factorial designs, crossover designs, randomized consent designs and adaptive assignment procedures. With all this diversity of approach it needs to be remembered that the effective implementation and reliability of a relatively straightforward randomization scheme may be more important than attempting theoretical optimality with more complex designs.

Clinical Trials as Topic↗
PubMed2026

A lipid-immune network signature defines susceptibility to asparaginase-associated pancreatitis.

BACKGROUNDAsparaginase is essential for curing acute lymphoblastic leukemia (ALL), but its use is limited by asparaginase-associated pancreatitis (AAP), a severe and unpredictable toxicity lacking validated prospective biomarkers. We sought to define early systemic molecular features of susceptibility to AAP.METHODSWe performed longitudinal lipidomic and proteomic profiling in two independent pediatric ALL cohorts (n = 161; 79 AAP cases, 82 controls) using paired blood samples collected before asparaginase exposure and at the end of induction therapy (including a single dose of asparaginase), thereby capturing pre-injury biology rather than consequences of pancreatitis. We applied differential abundance and network-based analyses and integrated lipid-cytokine associations using proteomics.RESULTSAcross cohorts, we identified a reproducible lysophosphatidylcholine-centered (LPC-centered) signature characterized by attenuated induction therapy-associated LPC responses and disruption of LPC coregulation at the network level. Proteomic profiling revealed enrichment of cytokine signaling pathways, and integrative analyses demonstrated altered lipid-cytokine coupling, including a flip in association direction for LPC species and IL-18 between cases and controls. Although IL-18/LPC ratios did not differ globally, elevated postinduction IL-18/LPC ratios identified AAP risk within a protocol-defined very high-risk ALL subgroup (AUC = 0.81).CONCLUSIONThese findings support a systems-level model in which failure of coordinated lipid-immune responses under therapeutic stress confers vulnerability to AAP, providing a framework for validation and mitigation strategies.TRIAL REGISTRATIONNCT00400946; NCT01574274; NCT03020030 (parent trials).FUNDINGServier Pharmaceuticals (IIT-95014-027-USA); SDRC (P30DK116074); Stanford SPARK; Fonds de Recherche du Qu&#xe9;bec - Sant&#xe9;; Fondation Charles-Bruneau; Leukemia & Lymphoma Society of Canada.

Adolescent↗
PubMed1977

Topical clotrimazole in tinea pedis.

Clotrimazole is a new antifungal agent which is effective topically in dermatophytosis, cutaneous candidiasis, and tinea vesicolor. The authors performed a controlled double-blind clinical trial comparing topical clotrimazole with its vehicle in the treatment of 66 patients with dermatophytic infections of the skin of the feet. Clotrimazole proved to be effective in the treatment of tinea pedis of both the interdigital and the plantar hyperkeratotic types.

Administration, Topical↗
PubMed1976

[The matched-pairs differences-W-test for evaluating clinical treatment effects in matched-pair samples (author's transl)].

Starting from the U-test (see Buck 1975), for 2 independent samples of differences (e.g. pre-post differences), a corresponding test for 2 dependent samples of differences of pre- and post-measurements of 2 treatments (e.g. verum vs. placebo) is described (matched-pairs differences-W-test). Clinically relevant applications (verum vs. placebo) of the matched-pairs differences-W-test are mentioned and discussed as to their restrictions.

Clinical Trials as Topic↗