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Results for “Clinical trials”

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
PubMed2026

Network-Integrated Platform for Clinical Trial Navigation from the New South Wales Early Phase Clinical Trials Alliance.

PURPOSE: Access to early-phase clinical trials (EPCT) is increasingly constrained by delays in genomic testing and lack of coordinated system-level navigation. The New South Wales Early Phase Clinical Trials Alliance (NECTA) was established to improve EPCT access. Practical Assessment of NECTA Network Assistance in Cancer Outpatient Trials Access (PANNA-COTA) prospectively evaluated whether integrating circulating tumor DNA (ctDNA) profiling with a real-time, cross-site molecular tumor board (MTB) facilitates EPCT enrollment. PATIENTS AND METHODS: In this multicenter prospective study across nine NECTA sites, patients referred for EPCT consideration underwent ctDNA testing using the Guardant360 74-gene assay. The results were reviewed at a fortnightly MTB incorporating cross-site trial mapping and dynamic eligibility review. The primary endpoint was proportion enrolled into EPCTs. Secondary endpoints included ctDNA findings and trial outcomes. RESULTS: Of 104 consented participants, 101 were eligible. Participants had advanced, heavily pretreated solid tumors; 48% lacked prior tumor next-generation sequencing. ctDNA alterations were detected in 85%, with actionable alterations in 44%. Therapeutic options were identified in 88%, and EPCTs were recommended in 76%. Despite this, only 7% of participants received genomically matched therapy. In contrast, 37% enrolled in EPCTs within 3 months and 47% overall [95% confidence interval (CI), 0.37-0.56]. Among evaluable participants on trial, the disease control rate was 81% and objective response rate was 33%. CONCLUSIONS: PANNA-COTA demonstrates that integrating liquid biopsy with real-time, network-level trial navigation enables high rates of EPCT enrollment despite low rates of genomically matched therapy. These findings indicate that clinical trial access is influenced by navigation, eligibility, and system-level coordination rather than genomic actionability alone.

Humans↗
PubMed1975

A fluid-filled intrauterine device: initial clinical trials.

Initial clinical trials of a saline-filled IUD were conducted with 697 women (397 nulliparas and 307 multiparas) experiencing 6,672 woman-months of use. The cumulative rates for multiparas were: pregnancy 1.5, expulsion 10.5, medical removal 10.9, continuation 68. For nulliparous women the rates were: pregnancy 4.3, expulsion 19.4, medical removal 14.3, continuation 58. Efforts are being made to modify the geometry and content of this IUD to decrease the expulsion rate and removals for bleeding.

Adolescent↗
PubMed1979

Iontophoretic application of idoxuridine for recurrent herpes labialis: report of preliminary clinical trials.

In clinical trials on six patients the antiviral drug idoxuridine (Stoxil) was applied by anodal (+) iontophoresis to 14 recurrent herpes labialis lesions. Results were characterized by immediate relief of discomfort and swelling, rapid appearance and coalescence of vesicles, minimal or no spread of the lesions, and accelerated healing with minimal or no scab. These encouraging trials indicate that a full-scale, double-blind, controlled clinical study should be carried out to determine whether iontophoresis is the optimal method of applying idoxuridine to the surface lesions caused by herpesvirus.

Adult↗
PubMedDate not supplied

Medical ethics and controlled clinical trials.

The controlled clinical trial is a relatively new phenomenon; the first large clinical trial on evaluation of streptomycin in therapy of pulmonary tuberculosis occurred in 1946. In such a study, two or more groups of patients with similar characteristics are chosen by random allocation to receive one or more therapies. The essential ethical dilemma is based on the risk-benefit ratio of the new therapy. Ethical factors that must be considered in the design of controlled clinical trials include provision for informed consent, nature of alternate therapy, confidentiality of data, source of funding and potential conflict of interest, remuneration of subjects, criteria for ending participation of the subject, criteria for concluding the trial, compensation of injured subjects, compliance with institutional, municipal, state and federal regulations and provisions for special groups such as the fetus and pregnant woman, infants and young children, institutional patients and prisoners. Federal guidelines for research in specific areas are now available through the reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. To date, commission reports include recommendations for research in fetuses and pregnant women and in children. Protection of the subject is best provided by the the quality of the protocol, integrity of the investigator, valid informed consent, and review of the research program by an independent committee composed of scientists and consumers.

Child↗
PubMed1979

Restricted randomization designs in clinical trials.

Though therapeutic clinical trials are often categorized as using either "randomization" or "historical controls" as a basis for treatment evaluation, pure random assignment of treatments is rarely employed. Instead various restricted randomization designs are used. The restrictions include the balancing of treatment assignments over time and the stratification of the assignment with regard to covariates that may affect response. Restricted randomization designs for clinical trials differ from those of other experimental areas because patients arrive sequentially and a balanced design cannot be ensured. The major restricted randomization designs and arguments concerning the proper role of stratification are reviewed here. The effect of randomization restrictions on the validity of significance tests is discussed.

Clinical Trials as Topic↗
PubMed1977

Radiotherapy and hyperbaric oxygen in head and neck cancer. Interim report of second clinical trial.

A controlled clinical trial is in progress to assess the value of hyperbaric oxygen and radiotherapy in the management of head and neck cancer. An established dose-fractionation schedule in hyperbaric oxygen is being compared with a widely used conventional schedule in air. Survival and local recurrence-free rates are significantly higher in the oxygen group, and the effects on normal tissue are similar in both groups. These findings suggest a genuine therapeutic advantage. There was a distinct improvement in the results of treating advanced laryngeal carcinoma, where there was a high survival rate, without resort to laryngectomy.

Clinical Trials as Topic↗
PubMed1979

Efficacy of metronidazole in dracunculiasis. A clinical trial.

In a clinical trial of metronidazole for dracunculiasis (75 cases), the drug was effective in giving symptomatic relief but had no preventive or vermicidal action. It was well tolerated. No difference was observed in the results of two dose schedules (200 mg or 400 mg three times daily for 10 days).

Dracunculiasis↗
PubMed1978

Chlorambucil dosage in frequently relapsing nephrotic syndrome: a controlled clinical trial.

A controlled clinical trial was performed using two dosage regimens of chlorambucil to treat children with frequently relapsing nephrotic syndrome. All children concurrently received prednisone (60 mg/m2 on alternate days). Ten children (Group I) were given chlorambucil as a stable dose (0.2 mg/kg/day) for 56 to 60 days, and 11 children (Group II) received increasing doses (0.2 to 0.63 mg/kg/day) for 42 to 77 days. Two children in each group subsequently relapsed. Follow-up averaged 28.6 and 27.2 months in Groups I and II, respectively. Three children in Group II developed infectious complications. The data indicate that a stable dosage regimen for chlorambucil is as effective as an increasing dose regimen in achieving long-term remission of frequently relapsing nephrotic syndrome.

Adolescent↗
PubMed1979

Research related to validation of treatment modalities by large-scale clinical trials.

The history of randomized, controlled, clinical trials is reviewed. Cooperative clinical trials are reviewed and summarized, and specific needs for future trials are identified. Improved policy on resource allocation decisions for clinical trials vs other forms of research is necessary, particularly as such trials begin to translate improved therapeutic knowledge into community level disease control.

American Heart Association↗
PubMed1979

Clobazam: uncontrolled and standard controlled clinical trials.

1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10-60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM-A). The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard-controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam).

Adjustment Disorders↗