scholarly journals Who is making clinical trials for treatment or prevention of COVID-19? A review of Clinicaltrials.gov, May 2020

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 823
Author(s):  
Martha Fors ◽  
Paloma González
Keyword(s):  
Nitric Oxide ◽  
Clinical Trials ◽  
Randomized Trials ◽  
Descriptive Study ◽  
Therapeutic Approaches ◽  
Open Label ◽  
Disease Treatment ◽  
Cross Sectional ◽  
Ongoing Research ◽  
Antimalarial Agents

Background: Coronavirus disease 2019 (COVID-19) has rapidly progressed into the worst pandemic in recent years. There are currently no approved therapies to treat the disease. Several clinical trials are being conducted to evaluate therapeutic approaches. Methods: We conducted a cross-sectional descriptive study to examine the main characteristics of COVID-19-related clinical interventional trials registered with ClinicalTrials.gov until May 15th, 2020. Results: We included 519 trials, most of which were phase II or III, open-label and randomized trials. Disease treatment was evaluated in 75.5% of trials, while prevention was evaluated in 12.1%. A total of 243 trials were listed as recruiting, and 42.4% were not yet recruiting. Approximately 20% of the analyzed trials are investigating antimalarial agents, while 10.2% are studying the use of convalescent plasma to treat the disease. Antiretrovirals, monoclonal antibodies, the use of stem cells, nitric oxide gases and vaccines are the most commonly evaluated therapies. As of the publication of this review, none of the clinical trials had uploaded results. Conclusions: ClinicalTrials.gov is an important database that contains ongoing research trials on COVID-19, a disease that is of vital importance. This study quantifies the outcomes of COVID-19-related clinical trials. The safety and effectiveness of many therapeutic approaches are investigated to fight this disease.

scholarly journals Clinical trials for treatment or prevention of COVID-19. A review of Clinicaltrials.gov.

F1000Research ◽  
2021 ◽  
Vol 9 ◽  
pp. 823
Author(s):  
Martha Fors ◽  
Paloma González
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Randomized Trials ◽  
Descriptive Study ◽  
Therapeutic Approaches ◽  
Open Label ◽  
Disease Treatment ◽  
Cross Sectional ◽  
Ongoing Research ◽  
Antimalarial Agents

Background: Coronavirus disease 2019 (COVID-19) has rapidly progressed into the worst pandemic in recent years. There are currently no approved therapies to treat the disease. Several clinical trials are being conducted to evaluate therapeutic approaches. Methods: We conducted a cross-sectional descriptive study to examine the main characteristics of COVID-19-related clinical interventional trials registered with ClinicalTrials.gov  from January to March 27th, 2020. . Results: We included 519 trials, 57.6% were phase II or III, open-label and randomized trials. Disease treatment was evaluated in 75.5% of trials, while prevention was evaluated in 12.1%. A total of 243 trials were listed as recruiting, and 42.4% were not yet recruiting. Approximately 20% of the analyzed trials are investigating antimalarial agents, while 10.2% are studying the use of convalescent plasma to treat the disease. Antiretrovirals, monoclonal antibodies, the use of stem cells, nitric oxide gases and vaccines are the most commonly evaluated therapies. As of the publication of this review, none of the clinical trials had uploaded results. Conclusions: ClinicalTrials.gov is an important database that contains ongoing research trials on COVID-19This study quantifies the outcomes of COVID-19-related clinical trials.  More than 500 studies have been  analyzed finding that most of these studies are interventional clinical trials  Phase II or III evaluating drugs or biological agents for the prevention or treating COVID-19.

scholarly journals Novel Therapeutic Approaches of Pulmonary Arterial Hypertension

2019 ◽  
Vol 28 (02) ◽  
pp. 112-117
Author(s):  
Sanjay Tyagi ◽  
Vishal Batra
Keyword(s):  
Nitric Oxide ◽  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Arterial Hypertension ◽  
Endothelin Receptors ◽  
Pulmonary Vasculature ◽  
Therapeutic Approaches ◽  
Uncommon Disease ◽  
Pulmonary Arterial ◽  
Novel Therapeutic

AbstractPulmonary arterial hypertension (PAH) is an uncommon disease characterized progressive remodeling of pulmonary vasculature. Although treatment for PAH have improved in last two decades but the outcome remains fatal. Currently, the therapies for PAH target three well-established pathways the nitric oxide (NO) pathway, endothelin receptors, and prostanoids. There are multiple potential targets for development of newer drugs in PAH which requires meticulous research and clinical trials.

Sildenafil for Pulmonary Hypertension

2005 ◽  
Vol 39 (5) ◽  
pp. 869-884 ◽  
Author(s):  
Audrey J Lee ◽  
Teresa B Chiao ◽  
Mildred P Tsang
Keyword(s):  
Nitric Oxide ◽  
Clinical Trials ◽  
Pulmonary Hypertension ◽  
Vascular Resistance ◽  
Resistance Index ◽  
Data Sources ◽  
Cochrane Library ◽  
Open Label ◽  
Vascular Effects ◽  
Double Blind

OBJECTIVE: To evaluate the efficacy of sildenafil for treatment of pulmonary hypertension. DATA SOURCES: Literature retrieval was accessed through MEDLINE (1977–March 2005), Cochrane Library, and International Pharmaceutical Abstracts (1977–March 2005) using the terms sildenafil and pulmonary hypertension. In addition, reference citations from publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles in English identified from the data sources were evaluated. Studies including >5 patients with primarily adult populations were included in the review. DATA SYNTHESIS: The treatment of pulmonary hypertension is challenging. Sildenafil has recently been studied as monotherapy and in combination with other vasodilators in the management of pulmonary hypertension. Eight hemodynamic studies and 12 clinical trials were reviewed (1 retrospective, 3 double-blind, 8 open-label). Sildenafil reduced pulmonary arterial hypertension and pulmonary vascular resistance/peripheral vascular resistance index and tended to increase cardiac output/cardiac index compared with baseline. Sildenafil was comparable to nitric oxide and at least as effective as iloprost or epoprostenol in terms of its pulmonary vasoreactivity. Combination therapy with iloprost, nitric oxide, or epoprostenol resulted in enhanced and prolonged pulmonary vascular effects. Clinical trials suggest that sildenafil improves exercise tolerance and New York Heart Association functional class, but large, randomized controlled trials are needed to confirm these findings. Overall, sildenafil was well tolerated. CONCLUSIONS: Overall, sildenafil is a promising and well-tolerated agent for management of pulmonary hypertension. Further well-designed trials are warranted to establish its place in the treatment of pulmonary hypertension.

scholarly journals Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kentaro Sakamaki ◽  
Yukari Uemura ◽  
Yosuke Shimizu
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Outcome Measures ◽  
Randomized Trials ◽  
Clinical Course ◽  
Time Frame ◽  
Phase Iii ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Sectional Analysis

Abstract Background There are several challenges in designing clinical trials for the treatment of novel infectious diseases, such as COVID-19. In particular, the definition of endpoints related to the severity, time frame, and clinical course remains unclear. Therefore, we conducted a cross-sectional analysis of phase III randomized trials for COVID-19 registered at ClinicalTrials.gov. Methods We collected the data from ClinicalTrials.gov on March 31, 2021, by specifying the following search conditions under Advanced Search: Condition or disease: (COVID-19) OR (SARS-CoV-2); Study type: Interventional Studies; Study Results: All Studies; Recruitment: Not yet recruiting, Recruiting, Enrolling by invitation, Active, Not recruiting, Suspended, Completed; Sex: All; and Phase: Phase 3. From the downloaded search results, we selected trials that met the following criteria: Primary Purpose: Treatment; Allocation: Randomized. We manually transcribed information not included in the downloaded file, such as Primary Outcome Measures, Secondary Outcome Measures, Time Frame, and Inclusion Criteria. In the analysis, we examined primary and secondary endpoints in trials with severe and non-severe patients, including the types of endpoints, time frame, clinical course, and sample size. Results A total of 406 trials were included in the analysis. The median numbers of endpoints in trials with severe and non-severe patients were 9 and 7, respectively. Approximately 25% of the trials used multiple primary endpoints. Regardless of the type of endpoint, the time frames were longer in the trials with severe patients than in the trials with non-severe patients. In the evaluation of the clinical course, worsening was often considered in binary endpoints, and improvement was considered in time-to-event endpoints. The sample size was the largest in clinical trials using binary endpoints. Conclusions Endpoints can differ with respect to severity, and the clinical course and time frame are important for defining endpoints. This study provides information that can facilitate the achievement of a consensus for the endpoints in evaluating COVID-19 treatments.

scholarly journals Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e041276 ◽  
Author(s):  
Christopher W Jones ◽  
Ashley L Woodford ◽  
Timothy F Platts-Mills
Keyword(s):  
Clinical Trials ◽  
Sequential Assignment ◽  
Open Label ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Research Activities ◽  
Accurate Treatment ◽  
Completion Date ◽  
Double Blinded ◽  
Sectional Analysis

ObjectivesTo characterise current COVID-19-related research activities.DesignCross-sectional analysis.SettingClinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19.Data sourcesClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic.Main outcome measuresWe classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date.ResultsOf the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020.ConclusionsThese findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.

scholarly journals Novel therapeutic approaches for the management of cystic fibrosis

2020 ◽  
Vol 15 ◽  
Author(s):  
Ryan Jaques ◽  
Arslan Shakeel ◽  
Cameron Hoyle
Keyword(s):  
Cystic Fibrosis ◽  
Recurrent Infection ◽  
Current Evidence ◽  
Therapeutic Approaches ◽  
Genetic Condition ◽  
Disease Treatment ◽  
Pharmacological Agents ◽  
Ongoing Research ◽  
Mucus Clearance ◽  
Made In

Cystic fibrosis (CF) is a genetic condition characterised by the build-up of thick, sticky mucus that can damage many of the body’s organs. It is a life-long disease that results in a shortened life expectancy, often due to the progression of advanced lung disease. Treatment has previously targeted the downstream symptoms such as diminished mucus clearance and recurrent infection. More recently, significant advances have been made in treating the cause of the disease by targeting the faulty gene responsible. Hope for the development of potential therapies lies with ongoing research into new pharmacological agents and gene therapy. This review gives an overview of CF, and summarises the current evidence regarding the disease management and upcoming strategies aimed at treating or potentially curing this condition.

scholarly journals A summary of current NKG2D-based CAR clinical trials

2021 ◽  
Author(s):  
Sophie Curio ◽  
Gustav Jonsson ◽  
Sonja Marinovic ◽  
Keyword(s):  
Clinical Trials ◽  
Tumor Cells ◽  
Treatment Options ◽  
Therapeutic Approaches ◽  
Ongoing Research ◽  
New Therapeutic Approaches ◽  
Important Player ◽  
Cancer Types ◽  
Stressed Cells ◽  
Cancer Immunotherapies

Abstract Cancer immunotherapies have significantly improved patient survival and treatment options in recent years. Nonetheless, the success of immunotherapy is limited to certain cancer types and specific subgroups of patients, making the development of new therapeutic approaches a topic of ongoing research. Chimeric antigen receptor (CAR) cells are engineered immune cells that are programmed to specifically eliminate cancer cells. Ideally, a CAR recognizes antigens that are restricted to tumor cells to avoid off-target effects. NKG2D is an activating immunoreceptor and an important player in anti-tumor immunity due to its ability to recognize tumor cells and initiate an anti-tumor immune response. Ligands for NKG2D are expressed on malignant or stressed cells and typically absent from healthy tissue, making it a promising CAR candidate. Here, we provide a summary of past and ongoing NKG2D-based CAR clinical trials and comment on potential pitfalls.

GAMBARAN TINGKAT PENGETAHUAN PERSONAL HYGIENE TENTANG MENSTRUASI PADA SISWI SMP

2019 ◽  
Vol 1 (2) ◽  
pp. 8-15
Author(s):  
Zaim Ashari
Keyword(s):  
Blood Vessels ◽  
Vaginal Discharge ◽  
Reproductive Tract ◽  
Sampling Technique ◽  
Total Sample ◽  
Descriptive Study ◽  
Reproductive Organs ◽  
Personal Hygiene ◽  
Cross Sectional ◽  
Hygiene Behavior

During menstruation blood vessels in the uterus are very easily infected because germs easily enter and cause diseases of the reproductive tract. Some of the most common disorders are vaginal discharge and pruritus vulvae (vaginal itching). However, this complaint can be prevented by maintaining the cleanliness of the female organs early on, namely with good menstrual personal hygiene. This study aims to describe the level of personal hygiene knowledge about menstruation. This research is a descriptive study with a cross-sectional approach, with a total sample of 90 people taken by total sampling technique. The results showed that the majority of respondents had enough personal hygiene behavior as many as 82 people (91.1%), while good menstrual personal hygiene behavior was 3 people (3.3%), and respondents who had behaviors classified as less than 5 people ( 5.6%). Based on complaints on reproductive organs, respondents who experienced vaginal discharge were 85 people (94.4%) and itching around the genitals was around 83 people (92.2%).

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