scholarly journals Osteoporosis-Related Randomized Clinical Trials With Middle-Aged and Older Adults Registered on the International Clinical Trials Registry Platform

2021 ◽  
Vol 12 ◽  
Author(s):  
Fenghua Lai ◽  
Ling Pei ◽  
Xinwen Chen ◽  
Jin Li
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Publication Rate ◽  
Middle Aged ◽  
Open Label ◽  
Or Education ◽  
Clinical Trial Designs ◽  
Clinical Trials Registry ◽  
Older Populations

BackgroundA better understanding of the current features of osteoporosis-related randomized clinical trials (RCTs) is important for improving clinical trial designs and promoting the translatability of results into benefits for patients. However, there is a lack of thorough evaluation of osteoporosis-related RCTs in middle-aged and older populations. Therefore, this study aimed to investigate the characteristics of registered RCTs on osteoporosis among middle-aged and older adults on the International Clinical Trials Registry Platform (ICTRP).MethodsOsteoporosis-related RCTs registered on the ICTRP were searched on December 31, 2020. The main features of eligible RCTs were assessed. We searched PubMed, Google scholar, Medline, and Embase databases for the publication status of completed RCTs.ResultsA total of 537 osteoporosis-related RCTs were identified for analysis. The number of registered RCTs increased rapidly in 2005 (N = 47). Of these, 346 (64.4%) RCTs involved only women and 275 (51.2%) were retrospectively registered. Most RCTs were of open-label design (61.3%). The most common primary purpose of osteoporosis-related RCTs was treatment (72.3%). Intervention investigated was mainly focused on medication (62.8%), followed by lifestyle or education (19.0%), and dietary supplement (10.4%). After trial completion, the results of only 140 (35.5%) RCTs were available on the ICTRP, and the publication rate after trial completion was 30.5%.ConclusionsRCTs on osteoporosis among middle-aged and older adults were dominated by retrospectively registered and open-label trials. Most trials lacked available results and associated publications. More awareness of prospective registration and blinding design in osteoporosis-related RCTs is needed. Further, publication and dissemination of RCTs results should be promoted.

scholarly journals Topical Corticosteroids a Viable Solution for Oral Graft versus Host Disease? A Systematic Insight on Randomized Clinical Trials

Medicina ◽  
2020 ◽  
Vol 56 (7) ◽  
pp. 349
Author(s):  
Arin Sava ◽  
Andra Piciu ◽  
Sergiu Pasca ◽  
Alexandru Mester ◽  
Ciprian Tomuleasa
Keyword(s):  
Clinical Trials ◽  
Graft Versus Host Disease ◽  
Randomized Clinical Trials ◽  
Open Label ◽  
Double Blind ◽  
Host Disease ◽  
Graft Versus Host ◽  
Overall Response ◽  
Topical Corticosteroids ◽  
Oral Gvhd

Background and Objectives: This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD). Materials and Methods: An electronic search of the PubMed, Web of Science and Scopus databases was carried out for eligible RCTs. Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English. The Cochrane Risk of Bias tool was used to assess the quality of these studies. Overall, three RCTs were included (an Open, Randomized, Multicenter Trial; a Randomized Double-Blind Clinical Trial; and an Open-Label Phase II Randomized Trial). Results: The trials involved 76 patients, of which 44 patients received topical dexamethasone, 14 patients received topical clobetasol and 18 patients received topical budesonide. Topical agents were most frequently used when oral tissues were the sole site of involvement. It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters. Moreover, both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone. Conclusions: Based on the clinical trials, all three agents seem to be effective in treating oral GVHD and had a satisfactory safety profile. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort.

scholarly journals Antihypertensive Agents in Older Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

2019 ◽  
Vol 104 (5) ◽  
pp. 1575-1584 ◽  
Author(s):  
Mohammad Hassan Murad ◽  
Laura Larrea-Mantilla ◽  
Abdullah Haddad ◽  
Gabriela Spencer-Bonilla ◽  
Valentina Serrano ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Antihypertensive Agents

Metoclopramide: dose-related toxicity and preliminary antiemetic studies in children receiving cancer chemotherapy.

1985 ◽  
Vol 3 (8) ◽  
pp. 1136-1141 ◽  
Author(s):  
J C Allen ◽  
R Gralla ◽  
L Reilly ◽  
M Kellick ◽  
C Young
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Cancer Chemotherapy ◽  
Randomized Clinical Trials ◽  
Dose Range ◽  
Toxicity Study ◽  
Dose Increase ◽  
Younger Adults ◽  
Nonrandomized Trial ◽  
Safe Dose

Prior studies in adults have shown that metoclopramide (MCP), when given in high intravenous (IV) doses (2 mg/kg), is a highly effective antiemetic for chemotherapy-induced vomiting. It is well-tolerated in older adults, but younger adults have an increased disposition to acute extrapyramidal reactions (EPRs). Before studying the efficacy of MCP as an antiemetic in children, we first had to establish the safe dose range. We performed a dose-increase MCP toxicity study in children receiving highly emetic chemotherapy such as cisplatin (120 mg/m2) or cyclophosphamide (greater than 900 mg/m2), beginning with a dose of 0.2 mg/kg and increasing the dose in nine steps to 3 mg/kg. MCP was given every two hours for four doses beginning one-half hour before chemotherapy. To reduce the incidence of EPRs, we added concomitant diphenhydramine. In MCP doses less than 2 mg, toxicity was minimal. In doses greater than or equal to 2 mg, 4/27 (15%) had EPRs and 9/27 (33%) had akathisia. Children who received two consecutive days of MCP had a higher frequency of EPRs. Metoclopramide (2 mg/kg) had promising antiemetic efficacy in a preliminary nonrandomized trial. Chemotherapy-experienced children vomited fewer than five times in 9/21 (43%) trials, and new patients vomited fewer than five times in 7/10 (70%) trials. MCP will become more useful as an antiemetic in children if better measures to prevent EPRs can be developed. Chemotherapy-induced emesis has the same negative implications in children as it does in adults and optimum antiemetic regimens can only be discovered by conducting randomized clinical trials in children.

Inclusion of Older Adults in Randomized Clinical Trials for Systemic Medications for Atopic Dermatitis

2020 ◽  
Vol 156 (11) ◽  
pp. 1240
Author(s):  
Megan Lam ◽  
Jie Wei Zhu ◽  
Talha Maqbool ◽  
Gaelen Adam ◽  
Mina Tadrous ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Atopic Dermatitis ◽  
Randomized Clinical Trials

scholarly journals Impact of Short-Acting vs Long-Acting Testosterone Therapy on Intratesticular Testosterone Using Data From Two Open-Label Randomized Clinical Trials of Testosterone Pellets, Injections, and Intranasal Gel in Hypogonadal Men

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A758-A759
Author(s):  
Eliyahu Kresch ◽  
Daniel Gonzalez ◽  
Jesse Ory ◽  
Sirpi Nackeeran ◽  
Ruben Blachman-Braun ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Wilcoxon Test ◽  
Testis Size ◽  
Open Label ◽  
Hpg Axis ◽  
Short Acting ◽  
Men 2 ◽  
Long Acting

Abstract Introduction & Objective: Exogenous testosterone (T) replacement therapy (TRT) is typically long-acting and can potentially cause infertility in a majority of men due to suppression of HPG axis. Intratesticular testosterone is vital for spermatogenesis and can be reliably evaluated with serum 17-hydroxyprogesterone (17-OHP). Based on this observation, we hypothesized that we used serum 17-OHP as a serum biomarker for evaluating intratesticular T in men receiving TRT. We hypothesized that long-acting TRT will have a significant impact on suppressing HPG axis as compared to short-acting preparations. We evaluated data from two simultaneous open-label, randomized, two-arm clinical trials amongst different treatment preparations (Trial I) subcutaneous T pellets and (Trial II) Intranasal Testosterone (Natesto) or Intramuscular Testosterone cypionate (TC). Subject & Methods: Hypogonadal men (2 AM serum T < 300 ng/dL assayed by LC-MS/MS) aged 18-65 years were randomized into open-label randomized clinical trials. Eligible subjects received: 800mg subcutaneous Testopel T pellets (n=47); or 11mg TID Intranasal testosterone (Natesto) (n=10) or 200mg x 2 weeks TC (n=10) for 2 months. Serum T and 17-OHP were collected at baseline and after 2 months of therapy. Data are presented as a post-hoc analysis of the two randomized clinical trials and reported as the median and interquartile range [25th-75th], paired sample analysis (baseline versus follow-up) was performed with the Wilcoxon test to determine change during time within the different TRT modalities, with p<0.05 considered significant. Results: Median change for serum T between baseline and 2mo follow-up to subcutaneous T pellets was 542 [454-757] ng/dL, Intranasal Testosterone 706 [517-1010] ng/dL, and TC 525 [280-712]ng/dL.; 96% of subjects in each trial achieved mean T concentrations in the eugonadal range. We demonstrated that serum T levels were within normal range among men receiving the various therapies. As expected, we found a statistically significant decrease amongst the different T preparations in serum 17-OHP. Longer acting T preparations such as T pellets and TC demonstrated the greatest decrease in 17-OHP, from 41 [20.3-65.6] to 14 [10.3-20.8] ng/dL and 80 [48-121] ng/dL to 20 [17-36] ng/dL (p<0.001), respectively. Shorter acting T preparations such as Natesto demonstrated a statistically significant decrease in 17-OHP, from 52.5 [26-67] ng/dL to 26.5 [18-39.8]ng/dL (p=0.007), but to a lesser extent as compared to the longer-acting preparations. Conclusions: Natesto, and other short acting forms of TRT may help hyogonadal men maintain Intratesticular T that is critical for maintaining spermatogenesis. The differential effects of TRT on intratesticular T based on their half-lives is novel and should be considered during the decision making for hypogondal men who wish to preserve fertility and / or testis size.

scholarly journals An Update on Antiviral Therapy Against SARS-CoV-2: How Far Have We Come?

2021 ◽  
Vol 12 ◽  
Author(s):  
Omkar Indari ◽  
Shweta Jakhmola ◽  
Elangovan Manivannan ◽  
Hem Chandra Jha
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Drug Repurposing ◽  
Clinical Findings ◽  
Open Label ◽  
Plasma Therapy ◽  
Clinical Safety ◽  
Treatment Research ◽  
Repurposed Drugs ◽  
Approved Drugs

COVID-19 pandemic has spread worldwide at an exponential rate affecting millions of people instantaneously. Currently, various drugs are under investigation to treat an enormously increasing number of COVID-19 patients. This dreadful situation clearly demands an efficient strategy to quickly identify drugs for the successful treatment of COVID-19. Hence, drug repurposing is an effective approach for the rapid discovery of frontline arsenals to fight against COVID-19. Successful application of this approach has resulted in the repurposing of some clinically approved drugs as potential anti-SARS-CoV-2 candidates. Several of these drugs are either antimalarials, antivirals, antibiotics or corticosteroids and they have been repurposed based on their potential to negate virus or reduce lung inflammation. Large numbers of clinical trials have been registered to evaluate the effectiveness and clinical safety of these drugs. Till date, a few clinical studies are complete and the results are primary. WHO also conducted an international, multi-country, open-label, randomized trials-a solidarity trial for four antiviral drugs. However, solidarity trials have few limitations like no placebos were used, additionally any drug may show effectiveness for a particular population in a region which may get neglected in solidarity trial analysis. The ongoing randomized clinical trials can provide reliable long-term follow-up results that will establish both clinical safety and clinical efficacy of these drugs with respect to different regions, populations and may aid up to worldwide COVID-19 treatment research. This review presents a comprehensive update on majorly repurposed drugs namely chloroquine, hydroxychloroquine, remdesivir, lopinavir-ritonavir, favipiravir, ribavirin, azithromycin, umifenovir, oseltamivir as well as convalescent plasma therapy used against SARS-CoV-2. The review also summarizes the data recorded on the mechanism of anti-SARS-CoV-2 activity of these repurposed drugs along with the preclinical and clinical findings, therapeutic regimens, pharmacokinetics, and drug-drug interactions.

scholarly journals POST-PARTUM DEPRESSION- TREATMENT UPDATE

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Vijay Choudhary ◽  
Sangeeta Hatila ◽  
Shubham Mehta
Keyword(s):  
Clinical Trials ◽  
Pharmacological Treatment ◽  
Randomized Clinical Trials ◽  
Post Partum ◽  
Antidepressant Drug ◽  
Mental Health Issue ◽  
Psychological Interventions ◽  
Omega 3 ◽  
Open Label ◽  
Post Partum Depression

Background: Postpartum depression is a prevalent and serious mental health issue in India. This affects not only a woman but also the development of her offspring. There is a need to find out various pharmacological and non-pharmacological treatment options available for the treatment post-partum depression. Method: This review was based on methods and results as described in the selected published articles available on PubMed and PsycINFO. We identified articles whose titles contained the following key terms in various combinations of the following: depression, depressive illness, postpartum, postnatal, treatment, prevention, therapy, pharmacotherapy, and antidepressant, the name of each antidepressant drug, hormonal therapy, estrogen, and progesterone. Results: We reviewed treatment of post-partum depression with antidepressants randomized clinical trials as well as open label studies, hormonal treatment, prevention studies randomized clinical trials as well as open label studies, alternative pharmacological treatment including omega-3- fatty acids- both for prevention and treatment. We also reviewed internet based intervention, cognitive behavioral therapy, kangaroo mother care, effectiveness of regular exercise, role of ECT and effect of rTMS in post part depression. When it’s about safety, the psychological interventions support their use in some women, pregnant and lactating women because of devoid of side effects to new born. Conclusion: Diverse pharmacological or psychological interventions options are available for treatment of postnatal depression. The most promising intervention is the focus on intensive and individualized approach.

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