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Results for “Controlled 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
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↗
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↗
PubMed2003

A phase III, multicenter, randomized, placebo-controlled clinical trial of topical aminocaproic acid (Caprogel) in the management of traumatic hyphema.

OBJECTIVE: To determine the safety and efficacy of topical aminocaproic acid (Caprogel) in the management of traumatic hyphema. DESIGN: Multicenter, randomized, double-masked, placebo-controlled clinical trial. PARTICIPANTS: A total of 51 patients participated in this trial (power = 36%, 2-tailed test). INTERVENTION: Patients presenting with traumatic hyphema were randomly assigned to 5-day treatment with topical aminocaproic acid or a placebo gel. Patients were monitored daily with ocular examination and vital sign testing for the 5 days of treatment and at 24 and 48 hours after treatment. General physical examination and laboratory testing were performed at baseline and day 5. MAIN OUTCOME MEASURES: The main efficacy variable was the rate of rebleeding. Secondary efficacy variables included time to hyphema clearance, intraocular pressure, time to secondary hemorrhage, and visual acuity. Safety variables included adverse events, vital signs, and laboratory measurements. RESULTS: Rebleeding occurred in 30% of the placebo group (8 of 27; 95% confidence interval [CI] = 14-50%), versus 8% of the treatment group (2 of 24; 95% CI = 1-27%), for an estimated continuity-corrected difference in percentage of patients with bleeding of 17% (95% CI = -3-38%). Secondary efficacy variables were similar in the groups, except that there was a trend towards more visual improvement in the topical aminocaproic acid group (54%) than in the placebo group (30%) at the last measurement (P = 0.08). Adverse events were similar. CONCLUSIONS: This study provides evidence that topical aminocaproic acid is safe and demonstrates trends towards reducing the rebleeding rate in the management of traumatic hyphema. However, because the study was terminated before complete enrollment, more definitive recommendations will require a larger trial.

Administration, Topical↗
PubMed2001

Can placebo controls reduce the number of nonresponders in clinical trials? A power-analytic perspective.

BACKGROUND: There is ongoing debate regarding the ethics of placebo-controlled clinical trials when a moderately effective standard treatment exists. One aspect of the debate--the number of nonresponders--tends to be overlooked. A larger between-group effect size is expected in placebo-controlled trials than in trials with an active comparator. For that reason, substantially fewer subjects need to be enrolled in placebo-controlled trials; consequently, there tend to be far fewer nonresponders in placebo-controlled trials. OBJECTIVE: This analysis was undertaken to illustrate that the use of placebo as a control can reduce the number of subjects who are unnecessarily exposed to delayed treatment. METHODS: Statistical power analyses were used to estimate the sample size required to detect various population treatment differences and the resulting number of nonresponders for 2-tailed chi-square tests. RESULTS: Empiric evidence of the phenomenon is provided for a wide range of rates of response to placebo, investigational, and comparator treatments. For example, 24 subjects (ie, 12 per group) are needed to detect differences between placebo (10% response rate) and an investigational drug (70% response); 15 of these would not respond. In contrast, if the investigational drug (70% response) is initially compared with a standard therapy (60% response), 752 subjects would be required, 263 of whom would not respond. CONCLUSIONS: This paper shows empirically that placebo controls can reduce the number of nonresponders in a randomized controlled trial. The number of subjects who are exposed to unproven, albeit promising, investigational drugs should be kept to a minimum until placebo-controlled trials support their use.

Clinical Trials as Topic↗
PubMed2004

New developments in medical clinical trials.

This paper reviews several new developments and long-standing good practices for conducting clinical trials. Discussion starts with the need for clear statements of study objectives, proceeds to clarify target and sample population, and elaborates on primary vs. secondary variables with the need for alpha adjustment in the presence of multiple outcomes. Here we also review the issue of surrogate endpoints. Study design issues--including blinding, randomization, and multicenter studies--come next. Then we discuss the current trend of the replacement of placebo-controlled trials by active controlled non-inferiority trials, the increasing use of Independent Data Monitoring Committees, the prominence of analysis on Intention-to-Treat samples, and the importance of imputation of missing data. We close with a brief discussion of the unit of analysis, the role of newer statistical analysis methods, safety issues, subset analysis, and, most importantly, clinical significance.

Clinical Trials Data Monitoring Committees↗
PubMed2007

Drug treatment of trigeminal neuralgia: a systematic review of the literature.

PURPOSE: This study undertook a systematic review of the literature on drug treatment of trigeminal neuralgia. METHODS: An electronic search was carried out for articles published between January 1960 to February 2005. Studies with high level of evidence were included. The levels of evidence of the articles were classified after the guidelines of the Oxford Centre for Evidence-Based Medicine. RESULTS: Of 770 publications, only 21 publications showed a high level of evidence (6 randomized controlled trials and 15 clinical trials/controlled clinical trials), with a total of 348 patients. A total of 749 publications were not included in the review as they showed a low level of evidence. CONCLUSIONS: Anticonvulsants are effective in treating trigeminal neuralgia; however, few studies with high levels of evidence were found. It is quite difficult to compare or even combine their outcomes in a scientifically meaningful manner. Due to insufficient research data, there is a need for high-quality randomized controlled trials in this area of medicine.

Anticonvulsants↗
PubMed2005

Orthodontic Clinical Trials III: reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998.

AIMS: The aims of this study were to assess whether reports of orthodontic clinical trials complied with the requirements of the Declaration of Helsinki. DESIGN: A retrospective observational study. SETTING: The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Journal of Orthodontics (formerly and up until 1999 known as the British Journal of Orthodontics, BJO) and European Journal of Orthodontics (EJO). DATA SOURCE: Clinical trials published between 1989 and 1998. METHODS: A hand search was performed to identify all clinical trials. Each trial report was assessed for inclusion of a statement that ethical approval and/or informed consent had been obtained. RESULTS: One-hundred-and-fifty-five papers were identified, of which 85 (54.8%) were reports of randomized controlled trials (RCTs) and 70 (45.2%) of controlled clinical trials (CCTs). 16.1% (25/155), of the trial reports stated that ethical approval had been obtained and a quarter (39/155, 25.1%) indicated that informed consent had been obtained. CONCLUSIONS: Most orthodontic clinical trial reports failed to state whether ethical approval and/or informed consent had been obtained. The reporting of the ethical issues associated with orthodontic clinical trials could be improved further not only by the instructions to authors in orthodontic journals stating the need for studies to comply with the Declaration of Helsinki, but also by Journal editors refusing to publish trials that do not comply.

Clinical Trials as Topic↗
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↗
PubMed2004

A randomized controlled clinical trial of topical photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratoses in transplant recipients.

BACKGROUND: Transplant recipients have an increased propensity to develop multiple actinic keratoses, which demonstrate an increased transformation rate into invasive squamous cell carcinoma. OBJECTIVE: To evaluate the efficacy and tolerability of topical photodynamic therapy with the new highly tumour-selective photosensitizer methyl aminolaevulinate vs. placebo in the treatment of actinic keratoses in transplant recipients. METHODS: Seventeen transplant recipients with a total number of 129 mild to moderate actinic keratoses were enrolled in a prospective, randomized, double-blind, placebo-controlled study. Two lesional areas within a patient were randomized for two consecutive treatments of topical photodynamic therapy 1 week apart using either methyl aminolaevulinate or placebo cream. Sites were illuminated with 75 J cm(-2) of visible light delivered at 80 mW cm(-2) by a noncoherent light source. Complete resolution and reduction in the number or size of actinic keratoses within the lesional area relative to the initial findings were evaluated at weeks 4, 8 and 16 after treatment. RESULTS: The lesional areas treated with methyl aminolaevulinate were clinically cleared in 13 of 17 patients at 16 weeks. A partial response was recorded in a further three. No reduction in the size or number of actinic keratoses was observed in one area treated with methyl aminolaevulinate and in all placebo-treated areas. Adverse events, such as erythema, oedema and crust formation, were mild to moderate, and treatment was well tolerated by all patients. CONCLUSION: Photodynamic therapy using methyl aminolaevulinate is a safe and effective treatment for actinic keratoses in transplant recipients. It may also reduce the risk of transformation of actinic keratoses to invasive, potentially fatal, squamous cell carcinoma.

Adult↗
PubMed2004

A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting.

Topical negative pressure has been demonstrated to improve graft take in a number of noncomparative studies. This study aimed to assess whether split-thickness skin graft take is improved qualitatively or quantitatively with topical negative pressure therapy compared with standard bolster dressings. A blinded, prospective, randomized trial was conducted of 22 adult inpatients of Liverpool Hospital between July of 2001 and July of 2002 who had wounds requiring skin grafting. After grafting, each wound half was randomized to receive either a standard bolster dressing or a topical negative pressure dressing. Skin graft assessment was performed at 2 weeks by a single observer blinded to the randomization. Two patients were lost to follow-up and were excluded from the study. There were 20 patients (12 men and eightwomen) in the study group. The median patient age was 64 years (range, 27 to 88 years), and the mean wound size was 128 cm2 (range, 35 to 450 cm2). The wound exposed subcutaneous fat in eight patients, muscle in six patients, paratenon in four patients, and deep fascia in two patients. At 2 weeks, wounds that received a topical negative pressure dressing had a greater degree of epithelialization in six cases (30 percent), the same degree of epithelialization in nine cases (45 percent), and less epithelialization in five cases (25 percent) compared with their respective control wounds. Graft quality following topical negative pressure therapy was subjectively determined to be better in 10 cases (50 percent), equivalent in seven cases (35 percent), and worse in three cases (15 percent). Although the quantitative graft take was not significant, the qualitative graft take was found to be significantly better with the use of topical negative pressure therapy (p < 0.05). Topical negative pressure significantly improved the qualitative appearance of split-thickness skin grafts as compared with standard bolster dressings.

Adult↗
PubMed2005

Topical glyceryl trinitrate application in the treatment of chronic supraspinatus tendinopathy: a randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Topical glyceryl trinitrate therapy has previously demonstrated short-term pain reduction in patients with supraspinatus tendinopathy. HYPOTHESIS: Topical glyceryl trinitrate improves outcome measures in patients with supraspinatus tendinopathy. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 1. METHODS: Fifty-three patients (57 shoulders) were recruited, and the authors completed a prospective, randomized, double-blinded, placebo-controlled clinical trial of continuous topical glyceryl trinitrate treatment (1.25 mg/24-h glyceryl trinitrate). RESULTS: The glyceryl trinitrate group had significantly reduced shoulder pain with activity, at night, and at rest at week 24 (P = .03); reduced internal rotation impingement at week 24 (P = .02); increased range of motion in abduction and internal rotation at week 24 (P = .04); and increased force at weeks 12 and 24 with supraspinatus muscle testing (P = .001), external rotation (P = .04), internal rotation (P = .01), adduction (P = .04), and subscapularis pushoff (P = .01). Forty-six percent of patients on glyceryl trinitrate patches were asymptomatic with activities of daily living at 6 months compared with 24% of patients with tendon rehabilitation alone (P = .007, chi(2) analysis). Mean effect size for all outcome measures was 0.26. DISCUSSION: Topical glyceryl trinitrate treatment significantly improved pain scores, range of motion, internal rotation impingement, muscular force, and patient outcomes in patients with supraspinatus tendinopathy. Topical glyceryl trinitrate should be included as part of nonsurgical management of chronic tendinopathies.

Administration, Topical↗
PubMed1983

Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin.

A prospective, controlled trial of antibiotic therapy was carried out in 90 patients with perforated appendicitis. One randomly selected group received systemic metronidazole, started peroperatively, plus locally instilled ampicillin. The other group, also randomly selected, received only local ampicillin. There was no statistically significant difference in the overall frequency of postoperative septic complications (wound infection or intra-abdominal abscess) between the two groups, but wound infections were significantly fewer in the patients given metronidazole. There was no intergroup difference in hospitalization time. Treatment with systemic metronidazole and local ampicillin is recommended in patients operated on for perforated appendicitis.

Adolescent↗
PubMed1980

Controlled clinical trial of oral and topical diethylcarbamazine in treatment of onchocerciasis.

In a double-blind controlled clinical trial comparing the safety and efficacy of oral diethylcarbamazine citrate (DEC) with topical DEC for the treatment of onchocerciasis twenty men with moderate skin-snip microfilarial counts received daily therapy for 1 week, then weekly therapy for the rest of 6 months. The number of microfilariae per skin snip dropped quickly to 2% of initial levels and remained at low levels in those receiving oral DEC, and to 20% of initial levels in patients treated with DEC lotion. Side-effects in both groups included lymphadenopathy, fever, pruritus, rash, proteinuria, and chorioretinitis; they were commoner with topical DEC.

Administration, Oral↗