Introduction to Trials Enrolling

RESULTS A total of eleven trials enrolling 6291 patients were included, of which 75.

This literature review includes medication treatment data from clinical trials enrolling individuals with features of OPT, including acquired pendular nystagmus (APN).

RESULTS Thirteen randomized controlled trials enrolling 1111 patients were included.

Gene therapy using adenoviruses encoding the immunostimulatory gene CD40L (AdCD40L) has shown promise in initial clinical trials enrolling human patients with various malignancies including melanoma.

However, no sex-specific guidelines on PCI and the use of DES are available as current evidence was derived from clinical trials enrolling predominantly male patients.

Key Points Question How is disease burden associated with female representation in US-based clinical trials, and how are disease category and other clinical trial features associated with female representation in clinical trials? Findings In this cross-sectional study of 20 020 clinical trials enrolling more than 5 million participants between 2000 and 2020, clinical trials in the fields of oncology, neurology, immunology, and nephrology had the lowest female participant representation relative to corresponding disability-adjusted life-years.

Experimental Design: We pooled data from seven European multicenter phase II/III clinical trials enrolling 2,190 patients with newly diagnosed MM from 2003 to 2017.

SELECTION CRITERIA We included trials enrolling infants with NAS born to mothers with an opioid dependence with more than 80% follow-up and using randomised, quasi-randomised and cluster-randomised allocation to sedative or control.

RESULTS Five trials enrolling 11,542 patients allocated to antithrombotic regimens omitting (n = 5795) or including aspirin (n = 5747) were included.

RESULTS After a literature search and detailed evaluation, 9 randomized controlled trials enrolling 460 patients were included in the quantitative analysis.

Articles included expert recommendations and those reporting pain education programs used in clinical trials enrolling adults with chronic neuromusculoskeletal pain and published in English between 1990 and 2021.

BACKGROUND To estimate the extent and severity of atopic dermatitis (AD)-related skin lesions, clinical trials enrolling dogs with AD often use categorical scales such as the Canine Atopic Dermatitis Extent and Severity Index, 4th iteration (CADESI-04) and Canine Atopic Dermatitis Lesion Index (CADLI).

Two trials enrolling 195 adolescents accounted for 13.

MAIN RESULTS Thirty-one trials enrolling 1684 participants were included in the systematic review.

The aim of our systematic review is to gain more insight in reporting of bone metastases, skeletal-related events, and bone-specific outcome of treatment in clinical trials enrolling patients with EGFR-mutated lung cancer.

Results Fourteen trials enrolling 3,157,259 patients were included.

Meaning The studied formulation of FRM-0334 should not be investigated in future clinical trials enrolling participants with GRN haploinsufficiency; this study did not fully address the potential of histone deacetylase inhibition to alter GRN expression.

RESULTS: Ten trials enrolling 1502 preterm newborns were included.

The CTneoBC analysis, which included 12 trials enrolling over 11,950 patients, showed that patients experiencing a pathologic complete response (pCR; ypT0ypN0 or ypT0/isN0) have improved event-free and overall survival with the association between pCR and longterm outcomes being strongest in patients with triple negative breast cancer (TNBC) and in those with HER2+/hormone receptor-negative breast cancer receiving trastuzumab.

The present work systematically reviewed any clinical trials enrolling participants with constitutional thinness and bibliographic researches were performed between December 2018 and June 2020.

However, large-scale clinical trials enrolling heterogeneous patients are required to evaluate the clinical value of miRNAs.

0002) and in trials enrolling younger patients (P=0.

The primary endpoint was pCR, with sub-analyses based on PD-L1 expression and risk of relapse RESULTS: Five randomized trials enrolling 1496 TNBC patients were included.

Two authors independently selected the investigations according to the following criteria: (1) observational study or randomized clinical trials enrolling ≥ 50 hospitalized patients undergoing NIRS outside the ICU, (2) laboratory-confirmed COVID-19, and (3) at least the intra-hospital mortality reported.

Objective: The purpose of this study was to provide a cross-sectional view of all registered clinical trials enrolling patients with osteonecrosis of the jaw (ONJ).

METHODS The data from two Phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trials enrolling patients with psoriasis were pooled and analysed.

This stands in contrast to several recent trials enrolling up to several thousand patients and finding no difference.

In 2021 two large pragmatic trials enrolling critically ill patients will add substantial new data to address this controversy.

RESULTS A total of 2,500 AMICS patients have been enrolled in 15 clinical trials over 21 years with only four trials enrolling >80 patients.

SELECTION CRITERIA We included randomized controlled trials enrolling adults with bipolar disorder who were treated with lamotrigine, placebo or lithium.

RESULTS Four randomized controlled trials enrolling 33718 patients were included.

However, only a few clinical trials enrolling HCC patients actually distinguished NAFLD/NASH-related cases from other non-cirrhotic causes and therefore evidence is still lacking in this subset of patients.

In this review, we study two decades of efforts to improve upon the gemcitabine backbone - 67 phase II and III trials enrolling 16,446 patients - that culminated in the approvals of gemcitabine/nab-paclitaxel (Gem/NabP) and FOLFIRINOX.

In addition, two recent small trials enrolling non-ICU patients confirm the feasibility of using remote real-time CGM in the hospital (4,5).

Several cardiovascular outcome trials on sodium–glucose cotransporter 2 inhibitors (SGLT2i) have been released recently, including trials enrolling patients with congestive heart failure (CHF) and chronic kidney disease (CKD).

Methods and analysis A systematic search of electronic databases including MEDLINE and the Cochrane Library will be conducted to find clinical trials enrolling patients on haemodialysis that measure quality of life using either the kidney disease quality of life (KDQoL) or the short form 36 health survey (SF-36) (or any variation of these two measures).

Due to the lack of large-scale prospective studies, most published data come from single-institution, small-cohort studies, and treatment recommendations are based on the extrapolation of data from clinical trials enrolling only women.

Methods and Results We performed a meta‐analysis of aggregate data from randomized clinical trials enrolling participants receiving a percutaneous coronary intervention with stenting and assigned to either early aspirin discontinuation or DAPT.

MAIN RESULTS Four trials enrolling 317 infants met the inclusion criteria.

Conclusions and Relevance These findings suggest that NEN trials enrolling over the last decade were more focused on select tumor populations, compared with studies that began enrollment before 2010.

We included 31 trials enrolling 3,759 infants.

Future clinical trials enrolling higher numbers of Asian patients, and an increased understanding of differences in patient and tumor genetics between Asians and non-Asians, have the potential to incrementally improve the management of BC in Asian patients.

Nirsevimab is currently being investigated in Phase 3 trials enrolling healthy late-preterm and full-term infants.

Two randomized trials enrolling 529 patients and 23 observational studies enrolling 7296 patients proved eligible.

RESULTS: We included six clinical trials enrolling a total of 375 patients.

A strong renal protective role of SGLT2i has also emerged in trials enrolling patients with and without T2DM.

Results: Four trials enrolling 1086 patients were included.

Trials enrolling from North America exclusively had more proportional representation, enrolling an average of 31.

Altogether, 10 randomized controlled trials enrolling 594 participants were included.

For trials enrolling patients before 2000 (R2 = 0.

Thirty-one trials enrolling 2,202 participants were included.

Understanding characteristics of early deaths may yield recruitment considerations for clinical trials enrolling children at high risk of early death.

We included 82 randomized clinical trials enrolling a total of 40,249 participants.

Randomized phase III, and for tyrosine kinase inhibitors (TKIs) also randomized phase II trials enrolling advanced/metastatic NSCLC patients were included.

Results: Eight trials enrolling 3272 patients were included.