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Introduction
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow
Endpoint Selection – In clinical trials, the selection of appropriate study endpoints is critical for an accurate and reliable evaluation of the safety and effectiveness of a test treatment under investigation. In practice, however, there are usually multiple endpoints available for measurement of disease status and/or therapeutic effect of the test treatment under study. For example, in cancer clinical trials, overall survival, response rate and/or time to disease progression are usually considered as primary clinical endpoints for the evaluation of the safety and effectiveness of the test treatment under investigation. Once the study endpoints have been selected, the sample size required for achieving the study objective with a desired power is then determined. It, however, should be noted that different study endpoints may result in different sample sizes. In practice, it is usually not clear which study endpoint can best inform the disease status and measure the treatment effect. Moreover, different study endpoints may not translate one another although they may be highly correlated with one another. In practice, it is very likely that one study endpoint may achieve the study objective while the others may not. In this case, it is an interesting question that which endpoint is telling the truth.
Progabide
Published in Stanley R. Resor, Henn Kutt, The Medical Treatment of Epilepsy, 2020
PGB should be administered in three divided doses, with a gradual increase of the dose to reach 30 mg/kg in 10 to 15 days. It may be brought up to 40 to 50 mg/kg after the first month when no adverse effects are present. A reduction of seizure frequency, in responders, is usually appreciable within 1 to 2 months at full doses. In general, the therapeutic effect is maintained over time without developing tolerance.
Von Economo’s encephalitis
Published in Avindra Nath, Joseph R. Berger, Clinical Neurovirology, 2020
Anticholinergic medications were often beneficial, well tolerated, and tolerated in high doses [1]. These were the chief means of treatment until the availability of l-dopa. Mainly in the German literature there were multiple reports of the alkaloids, Harmin or Banisterine [91]. They chiefly affected the rigor and the hypokinesia with improvement in voluntary motor activity, strength and duration. Tremor was not affected [92]. Therapeutic effect on patients was variable. Long term treatment did not seem to have a negative effect on response [93]. Hyascin, which had a similar effect though with less dramatic improvement, made in general the patients subjective well-being better, so it was often used concomitantly [94]. Other authors achieved some therapeutical effect with high doses of Atropa belladonna, also known in the literature as the “Bulgarian treatment” [95].
Differences in Treatment Effects of Cognitive-behavioral Therapy for Insomnia Based on Sleep Reactivity: A Preliminary Study
Published in Behavioral Sleep Medicine, 2023
Kyunga Park, Goeun Kim, Jiyun Lee, Sooyeon Suh
In this study, we adopted a quasi-experimental pre-post design and provided CBT-I to all study participants. We classified participants into two levels (high and low) of sleep reactivity groups using the baseline median score of the group. We initially intended to use the cutoff score of 18 points on the Ford Insomnia Response to Stress Test (FIRST) to distinguish groups (Kalmbach et al., 2016b). However, only one participant scored below the predefined cutoff point, with potential participants volunteering for the study having overwhelmingly high sleep reactivity. Thus, for the purpose of this study, we used the median sleep reactivity of the participants (median score 28). As a result, we assigned nine out of 19 people to a group with high sleep reactivity and ten to a group with low sleep reactivity. Figure 1 illustrates the procedures for measuring data collection and therapeutic effects.
Pharmacotherapy considerations for morning symptoms in chronic obstructive pulmonary disease
Published in Expert Opinion on Pharmacotherapy, 2022
There is a paucity of data on the effects of dual long-acting bronchodilator therapy (LAMA/LABA fixed combinations) on morning symptoms in COPD. However, they improve health status and reduce dyspnea compared to monotherapy with LABA or LAMA. Thus, they may be considered for patients who have persistent morning symptoms on LABA or LAMA monotherapy. There are no data directly comparing twice-daily LAMA/LABA versus once-daily LAMA/LABA [12]. Similarly, there is a scarcity of studies that have compared once-daily triple- versus twice-daily triple therapy. A recent pool analysis of two phase IV trials showed that once-daily triple therapy (with fluticasone furoate/umeclidinium/vilanterol) was non-inferior to twice-daily budesonide/formoterol plus tiotropium bromide with regard to symptom burden, health status, or lung function measurements including morning flow rates [13]. However, these data should be interpreted cautiously as it did not directly evaluate morning symptoms. Theoretically, once-daily triple therapy (ICS/LABA/LAMA) may provide the steadiest and longest duration of action to address morning symptoms. However, some patients may still report differences in therapeutic effects depending on the time of administration, and therefore, this is an interesting and worthwhile area of further research.
Randomized trial of electrodynamic microneedling combined with 5% minoxidil topical solution for treating androgenetic alopecia in Chinese males and molecular mechanistic study of the involvement of the Wnt/β-catenin signaling pathway
Published in Journal of Dermatological Treatment, 2022
Linlin Bao, Haifeng Zong, Sining Fang, Lixiong Zheng, Yuanhong Li
The qRT-PCR and western blotting results of the present study also showed that FZD3 expression is closely related to treatment efficacy. Therefore, this gene can be used as a new target for the treatment of male AGA in future in-depth studies. However, this study also had limitations. First, the sample size was small; the main reason was that the specimens were difficult to collect. Therefore, in future studies, sample collection should be strengthened to increase the sample size. Second, during the study, only patients in the combination group received scalp massage after the microneedling treatments to enhance absorption of the drug. This might be an influential factor for the therapeutic effect. In future studies, scalp massage should be done to all patients to avoid the potential impact on the therapeutic effect. Lastly, when conducting human experiments, there are certain limitations in the research methods. In the future, new experimental methods should be explored to more intuitively observe the changes in hair follicles and their surrounding tissues.