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Designing Phase II Studies in the Context of a Programme of Clinical Research

Biometrics, 1985
Conventional statistical determinations of sample size in phase II studies typically lead to sample sizes of the order of 25 (Schoenfeld, 1980, International Journal of Radiation Oncology, Biology and Physics 6, 371-374). When the development of new treatments is proceeding rapidly relative to the recruitment of suitable patients, such requirements can
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PERCEPTION OF CLINICAL RESEARCH AMONG HEALTHY VOLUNTEER STUDIES AND HUMAN CLINICAL PHARMACOLOGY-PHASE-I CLINICAL TRIALS

INDIAN JOURNAL OF APPLIED RESEARCH
Purpose Clinical research relies on data from patients and volunteers, yet the target sample size is often not achieved. Here, we assessed the perception of clinical research among clinical trial participants to improve the recruitment process for future studies.
Mohammad Nadeem Khan, Ashok Kumar
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Multimodal Neuroimaging in Late-Life Mental Disorders: Entering a More Mature Phase of Clinical Neuroscience Research

The American Journal of Geriatric Psychiatry, 2008
Magnetic resonance imaging based neuroimaging approaches have led to a broader appreciation and understanding of the neurobiologic basis of mental disorders in the elderly. The diverse MRI related approaches include morphometry, functional MRI (fMRI), magnetization transfer (MT), and diffusion tensor imaging (DTI).
Anand, Kumar   +2 more
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[Phase I clinical study of CPT-11. Research group of CPT-11].

Gan to kagaku ryoho. Cancer & chemotherapy, 1990
CPT-11 is a new derivative of Camptothecin. Phase I clinical study of single administration with CPT-11 was carried out by a cooperative study group. Starting from 50 mg/m2 (n), dose was escalated to 350 mg/m2 (7n). Dose limiting factor was found to be a decrease in WBC counts (especially in neutrophils), and MTD was presumed to be 250 mg/m2 or more ...
T, Taguchi   +6 more
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[Phase I clinical study of TT-62. Research group of TT-62].

Gan to kagaku ryoho. Cancer & chemotherapy, 1993
TT-62 is a new derivative of FdUMP, which is the active metabolite of 5-FU. A phase I clinical study of TT-62 was conducted by a cooperative study. The same patients received single and 2-week oral administration of TT-62. Starting from 60 mg/m2 (1n), the dose was escalated to 420 mg/m2 (7n).
T, Taguchi   +9 more
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Application of Quantitative Phase Imaging mass accumulation measurements to research and clinical problems in cancer

Quantitative Phase Imaging V, 2019
The robustness of Quantitative Phase Imaging (QPI) has enabled QPI to be used in applications to answer both research and clinical questions. QPI requires no labels, is non-destructive, and has nanoscale sensitivity to 3-d morphology. Various applications have included recording cellular force dynamics, identifying parasite-infected red blood cells ...
Graeme Murray   +7 more
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[Two-phase respiration of apnoeic newborn, basic research and clinical value (author's transl)].

Geburtshilfe und Frauenheilkunde, 1977
Studies on fetal human and calf lungs proved an 1: 2,5 increase rate of the transpulmonary blood-flow after inflation of the alveolar spaces. The extent of the inflation depends on the function pressure X time. Based on the rupture rate of the pulmonary tissue, the factor pressure is limited to 20-30 ch H2O.
G, Jelko, D, Kress, K, Semm
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[The clinical phase I study of TNP-351. The TNP-351 Research Committee].

Gan to kagaku ryoho. Cancer & chemotherapy, 1995
The clinical phase I study of TNP-351, an antifolate drug having a novel structure, was performed through a multicenter cooperative program in 40 patients with solid tumors. The test drug was used on dosage schedules of single and daily doses for 5 or 3 days (by intravenous drip over 30 minutes, respectively).
T, Taguchi   +9 more
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Phase II trial of didox in advanced breast cancer. Cancer Research Campaign Phase I/II Clinical Trials Committee.

British journal of cancer, 1992
Fourteen patients with advanced breast cancer were treated with the ribonucleotide reductase inhibitor didox 6 g m-2 given by intravenous infusion over 36 h every 3 weeks. None responded and toxicity was minimal. Possibilities for the more effective use of this agent are discussed.
R D, Rubens   +5 more
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