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Results for “Clinical Trials as Topic”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 19 recordsLinked to original sources
PubMed2004

[Clinical trials--selected topics].

Clinical trials are a dynamic and complex research domain. Being the backbone of the clinical practice, clinical trials present a wide range of aspects. This overview deals with selected topics related to clinical trials, such as: factors influencing the choice of research issues, reasons for early termination of clinical trials, participating patients' access to experimental treatments following clinical trials, economic implications of clinical trials and the existence of publication bias in clinical research.

Clinical Trials as Topic↗
PubMed1983

Reproducibility of clinical trials of topical glucocorticosteroids.

Clinical trials of topical glucocorticosteroids employ a variety of evaluating methods. This makes it difficult to assess the relative strengths of the products without resorting to direct comparative trials between them. We propose a standardized evaluation system for this class of pharmaceuticals that can easily be adopted by any competent dermatologist. Its use would facilitate evaluation of new topical glucocorticosteroids.

Administration, Topical↗
PubMed1986

[Clinical trial of a topical preparation containing urea, sunflower oil, evening primrose oil, wheat germ oil and sodium pyruvate, in several hyperkeratotic skin conditions].

A topical clinical trial with preparations containing urea and sodium pyruvate has been made. It was used for diverse hyperkeratotic skin conditions (psoriasis, xerosis, pityriasis rubra pilaris, stuccokeratosis, seborrheic dermatitis, stasis dermatitis, pityriasis lichenoides chronica). A month later a clinical improvement was evident in all cases except in pityriasis lichenoides.

Administration, Topical↗
PubMed1980

Randomized clinical trial of topically administered cromolyn sodium for vernal keratoconjunctivitis.

We performed a controlled, randomized, double-masked, double-crossover clinical trial topically administered cromolyn sodium (4%) in 11 patientas with atopy and vernal keratoconjunctivitis. Statistically significant differences were noted in conjunctival injection, superifcial punctate keratitis, mucous production, and itching when eyes treated with cromolyn were compared to those treated with a placebo. The drug was well tolerated by all patients.

Adolescent↗
PubMed1992

A new topical treatment for acute herpetic neuralgia and post-herpetic neuralgia: the aspirin/diethyl ether mixture. An open-label study plus a double-blind controlled clinical trial.

Topical aspirin/diethyl ether (ADE) mixture was used to treat 45 consecutive patients with acute herpetic neuralgia (AHN) (n = 28) and with post-herpetic neuralgia (PHN) (n = 17) in an open-label study. Good-to-excellent results were achieved by 93% of AHN patients and by 65% of PHN patients. Earlier treatment yielded better results for the AHN but not the PHN group. The topical treatment seemed to accelerate the healing of acute herpetic skin lesions and possibly modulate the severity of the herpetic infection. Furthermore, a striking reduction in the percentage of AHN patients developing PHN was observed in the treated group, as compared with the disease natural history reported in the literature (4 vs. 50-70%). Treatment tolerance was excellent with no adverse effect observed. In addition to the open trial, a pilot double-blind crossover placebo-controlled study (n = 11) compared the analgesic efficacy of ADE with two other NSAID (indomethacin and diclofenac) drug/ether mixtures. Aspirin (but not indomethacin and diclofenac) was significantly superior to placebo as regards pain relief (P less than 0.05).

Acute Disease↗
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↗
PubMed1980

Chemotherapy of onchocerciasis: a controlled clinical trial of topical diethylcarbamazine (DEC) in Guatemala.

A double-masked, controlled clinical trial was conducted in Guatemala to assess the safety and efficacy of diethylcarbamazine (DEC) lotion as compared to placebo lotion in the treatment of onchocerciasis. One hundred eighty-seven people were enrolled in this study and were followed for two months. Lotion was applied daily for seven days, then weekly for seven weeks. The decrease in mean microfilarial counts per skin snip was significantly greater in those receiving DEC lotion than for those receiving placebo lotion. The proportionate reduction in microfilarial counts was similar for people with light, moderate, or heavy microfilarial loads. Side effects were mainly related to skin changes, fever, and malaise, and occurred in nearly one-third of the people receiving DEC lotion. These reactions occurred almost as commonly in those people who were lightly infected as in those who had moderate or heavy infections.

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↗
PubMed1981

Clinical trial of topical erythromycin in inflammatory acne.

Sixty-nine informed subjects participated in a split-face, double-blind trial of topical erythromycin base 2% in Vehicle/N versus Vehicle/N alone. All subjects had grades II or III acne as described by Pillsbury. Study solutions were assigned to a randomly selected side of the subject's face. Solutions were applied twice daily. Inflammatory lesion counts were performed by the same investigator during the eight weeks of study at biweekly intervals. The difference in inflammatory lesion counts from beginning to end of study for each side of the face was compared utilizing Student's paired t-test. There was not a statistically significant difference in mean inflammatory lesions at the end of eight weeks (D = 1.46, t = 1.36, df 68). There was, however, a significant difference at two and six weeks (D = 2.59, t = 3.72, df 68; D = 1.41, t = 2.03, df 68). Observed differences in lesion counts were not considered to be clinically significant.

Acne Vulgaris↗
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↗
PubMed1988

A randomized clinical trial of topical gentamicin after tympanostomy tube placement.

Purulent otorrhea is the most common complication of tympanostomy with tube placement. Some authors report an incidence of over 30%. We have evaluated topical gentamicin solution for prophylaxis in a controlled, randomized, prospective clinical trial. Nine patients of the 102 in the study developed otorrhea in the first two postoperative weeks. All nine were in the control group of 46. The 56 patients receiving prophylactic gentamicin had no cases of purulent otorrhea. Several other characteristics of the patients and the procedures were examined as possible risk factors for otorrhea. None were statistically significant, but the younger patients had a higher rate of infection. We recognize the theoretical risk of ototoxicity, but conclude that instillation of topical gentamicin is an effective prophylactic technique for preventing purulent otorrhea after tympanostomy.

Administration, Topical↗