Introduction to Trials Reported

What is/are Trials Reported?

Trials Reported - 6% ( n = 140) of trials reported results late. ^[1] A survey of authors of randomized trials of diabetes QI interventions included in an ongoing systematic review found that 78% of trials reported improved quality of care, but 40% of these trials were not sustained. ^[2] Trials reported in English involving adult patients with solid cancers treated with the combination durvalumab plus tremelimumab were retrieved; the references of the articles were cross-checked to identify missing papers. ^[3] The trials reported buprenorphine and extended-release naltrexone reduced opioid use. ^[4] While all trials reported race between 2013 and 2015, no consistent trend was seen towards increasing race reporting or in enrollment of black patients over time. ^[5] Sixty percent (confidence interval [CI] 53-68%) of trials reported sample size calculations, but only 32% (CI 25-39%) justified the expected effect size. ^[6] Whereas most trials did not signal an increased risk for thrombotic events, some trials reported an increased rate of thrombotic complications with the use of TXA for gastro-intestinal bleeding and trauma. ^[7] Nearly all (98%) trials reported pre-trial registration. ^[8] More recently, two Phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials reported efficacy for fixed, multi-site injections of onabotulinumtoxinA, which was licensed in 2010 as a rescue therapy for those patients with chronic migraine who had failed three prophylactic medications. ^[9] We considered quasi-randomised, cluster-randomised, and trials reported only in abstract form. ^[10] While the use of JAK inhibitors in patients suffering from AD is very promising, trials reported to date are of short duration (maximum 16 weeks), and more information on the long-term safety of these novel agents is required. ^[11] 53% of trials reported race in the licensing publication, however of this only 55% met current FDA recommendations. ^[12] Five of these trials reported results. ^[13] Treating 40-70% increase in velocity as a target, based on reports in the literature for the UK variant (VUI 202012/01), the series of trials reported in the paper demonstrate the calibration of CovidSIMVL parameters to produce increases in transmission rates of 40-70% above a baseline value. ^[14] Most of them were also recent trials reported within 4 years, which means there has been high clinical interest and unmet needs toward stent-related problems among urologists. ^[15] Simulations of the placebo response rate showed a rate of 22% with 80% of trials falling between 15 and 30%, in keeping with trials reported to date. ^[16] Results Subjects who conceal information in order to enroll in trials reported using concealment in about two thirds (67%) of the trials they participated in over the past 12 months. ^[17] Additionally, these same trials reported adverse events including cardiac, neuropsychiatric, hematologic, and hepatobiliary manifestations in patients with COVID-19 whom had been treated with HCQ. ^[18] Moreover, not any trials reported adverse events of polyphenol. ^[19] For harms (eg, anxiety or worry), the trials reported no significant differences between screening and control groups. ^[20] USA-based trials reported smaller effects. ^[21] Only 11% of the trials reported results, and 4% of the trials reported the race or ethnicity of the participants. ^[22] In the systematic review, 44% (25/57) of trials reported successful interventions; this was more common in open-label (70%, 19/27) compared to placebo-controlled studies (22%, 6/27). ^[23] Fifty-two percent of trials reported all components of exercise prescription, and 3% of trials reported the level of adherence to the prescribed exercise. ^[24] Overall, 62% of trials reported adverse events of any kind, although reporting of deaths or antibiotic resistance was less frequent (20% and 37%, respectively). ^[25] Nuclear cardiology substudies from these trials reported inconsistent results. ^[26] Due to small number and the poor quality of trials reported on this topic, the results of this review should be treated with caution. ^[27] 7% of the trials reported postprotocol therapies. ^[28] None of the trials reported on clinical endpoints. ^[29] Only a small proportion of trials reported sex-stratified results. ^[30] None of the trials reported on quality of life. ^[31] CONCLUSIONS We were surprised that so few trials reported the inclusion of elements of the therapeutic alliance when relational aspects of primary care are critical for effectiveness. ^[32] 7%) trials reported the pre-specified non-inferiority margin in registration, and 99 (28. ^[33] At the time of approval, 8 (16%) trials reported significant improvement in OS. ^[34] Almost 90% (7/8) of trials reported high adherence rates ranging from 73 to 95% for supervised group training and 63 to 80% for home self-practice. ^[35] All the trials reported impairment outcomes with a statistically significant difference between the experimental arm and the control arm in terms of their primary outcomes except one. ^[36] Fifty-eight per cent of the trials reported significant differences in the results, and 30. ^[37] For IOP data, none of the trials reported a difference between pairs of surgical techniques, nor changes in visual acuity or number of post-operative medications. ^[38] None of the trials reported prespecified enrollment targets by race/ethnicity criteria. ^[39] Trials reported in 2015 showed that the vaccine could prevent four in 10 cases of malaria and three in 10 severe cases. ^[40] None of the trials reported severe side effects. ^[41] Factors associated with improved overall quality score were the presence of a secondary publication dedicated to PROs results, the statement of any targeted dimensions, and when trials reported results using multiple methods. ^[42]

health related quality

No trials reported data on health-related quality of life, return to normal activity or return to work. ^[1] None of the trials reported health-related quality of life. ^[2] None of the trials reported health-related quality of life. ^[3] None of the included trials reported data on health-related quality of life, cancer-related mortality, time to recurrence of the tumour, and non-serious adverse events in participants with only cholangiocarcinoma. ^[4] None of the trials reported that they measured overall health-related quality of life using a validated scale. ^[5] No trials reported health-related quality of life. ^[6] Seven trials reported on health-related quality of life and symptom improvement using different methodologies. ^[7]

Clinical Trials Reported

Thus, herein we review outcomes of MDS patients after immunotherapies on a variety of clinical trials reported to date. ^[1] Initial clinical trials reported no major adverse events beyond rare cases of anaphylaxis. ^[2] Most randomized controlled clinical trials reported significant benefits by diabetes self-management education (DSME) on DSM behaviors and metabolic control. ^[3] 5% of cancer clinical trials reported the ethnic background of participants in their trials while even less 5% reported the efficacy or toxicology of the therapeutic intervention for ethnic minorities. ^[4] BACKGROUND While case reports and clinical trials reported withdrawal syndrome after reduction and/or discontinuation of antidepressant drugs, no large study has been conducted to compare the risk between the different antidepressants. ^[5] The majority (25 studies) of clinical trials and meta-analyses of clinical trials reported a beneficial effect of yogurt consumption in the prevention of MetS risk. ^[6] Results: Ten case series and clinical trials reported success parameters for treatment outcomes, and four additional for recurrence prophylaxis. ^[7] Two randomized clinical trials reported no differences in OS or MSS when complete lymph dissection was compared with observation alone. ^[8] Several clinical trials reported improved outcomes with the intensification of androgen deprivation therapy by the addition of docetaxel chemotherapy or novel hormonal agents (abiraterone, enzalutamide, or apalutamide) in the metastatic castration-sensitive state. ^[9] EVIDENCE REVIEW A cross-sectional review of phase 3 clinical trials reported in Clinicaltrials. ^[10] Although no clinical trials have been published in the peer-reviewed literature, results from two phase 3 clinical trials reported to ClinicalTrials. ^[11] Recent clinical trials reported that the use of Bruton’s tyrosine kinase (BTK) inhibitors to treat COVID-19 patients could reduce dyspnea and hypoxia, thromboinflammation, hypercoagulability and improve oxygenation. ^[12] The purpose of this systematic review is to provide an overview of the effectiveness of these two drugs based on the clinical trials reported in current published data. ^[13] Clinical trials reported different cutaneous adverse events, mainly local injection site reactions, either immediate or delayed on/after 8 days. ^[14] Few clinical trials reported serious adverse events, but they were unrelated to vaccination. ^[15] There are no comparative randomized or double-blinded spinal fusion clinical trials reported to date. ^[16]

No Trials Reported

No trials reported patient involvement in the commissioning or undertaking stages. ^[1] No trials reported data on health-related quality of life, return to normal activity or return to work. ^[2] No trials reported severe adverse events. ^[3] No trials reported on live birth or reduction of pain. ^[4] No trials reported quality of life or organ failure. ^[5] Pentoxifylline versus placebo No trials reported on our primary outcomes of live birth rate and overall pain. ^[6] No trials reported on quality of life or adverse outcomes. ^[7] No trials reported on cardiovascular mortality. ^[8] No trials reported adverse effects. ^[9] No trials reported an intervention adherence of 75% or more for a set prescription that meets current exercise guidelines. ^[10] No trials reported data on adverse effects in children (including constipation, nausea, vomiting, heartburn or diarrhoea), except for risk of infection or inflammation at the individual level. ^[11] No trials reported health-related quality of life. ^[12] No trials reported involvement of mothers to reflect patients’ top priorities in question definition or outcomes selection. ^[13]

Included Trials Reported

All of the included trials reported the baseline vitamin D status of participants. ^[1] The qualitative findings of the studies showed that major part of the included trials reported significant improvement in clinical periodontal parameters in periodontitis patients with the adjunctive use of probiotics compared with control group. ^[2] All the included trials reported that isolated RT improved both upper and lower limbs’ maximal strength. ^[3] None of the included trials reported on longer-term maternal outcomes, or on any infant outcomes. ^[4] The majority of the included trials reported their outcomes by PD-L1 expressions, with PD-L1 ≥ 50 being considered the most clinically useful cut-off level for decision makers. ^[5] None of the included trials reported data on health-related quality of life, cancer-related mortality, time to recurrence of the tumour, and non-serious adverse events in participants with only cholangiocarcinoma. ^[6] None of the included trials reported type 2 diabetes incidence or cardiovascular risk. ^[7] The included trials reported no significant changes in medication use. ^[8] Seven of the nine included trials reported data from infants with a maximum weight of between 1000 grams and 1400 grams. ^[9] None of our included trials reported respiratory exacerbations, quality of life or serious adverse events. ^[10] None of the included trials reported trabeculectomy failure at 24 months. ^[11]

Controlled Trials Reported

Of the 273 articles initially identified, eight randomized controlled trials reported nursing interventions mainly focused on patients’ ICU discharge preparation through information and education. ^[1] Recent double-blind, randomized, controlled trials reported that human umbilical cord-derived mesenchymal stem cell (MSC) infusions in COVID-19 patients with acute respiratory distress syndrome (ARDS) could diminish cytokine storm and lung damage. ^[2] Four randomized controlled trials reported the outcomes of extended thromboprophylaxis in 3655 medically ill patients with active or history of cancer. ^[3] A number of recent randomized controlled trials reported the efficacy of brain-computer interface (BCI) for upper-limb stroke rehabilitation compared with other therapies. ^[4] A total of 4 of the 6 randomized controlled trials reported positive and significant results, including decreased emotional distress and increased health service navigation, self-efficacy, social participation, and constructive attitudes and approaches. ^[5] Several controlled trials reported benefit of everolimus (EVR) in minimizing this risk when combined with a reduced CnI dose. ^[6] Three controlled trials reported a moderate benefit from paracervical block up to 8 hours after vaginal and 4 hours after laparoscopic surgery. ^[7] RESULTS: A total of 14 randomized controlled trials reported 1,951 peptic ulcer patients, 977 and 974 of which were in the control and intervention groups, respectively. ^[8] None of the randomized controlled trials reported the total urine output, whereas one reported that no participants required RRT. ^[9] Several meta-analyses of randomized controlled trials reported that iron administration improved HF symptoms, exercise capacity, and clinical outcomes in iron-deficiency patients with HF with reduced EF. ^[10]

Two Trials Reported

All six trials measured reduction in the number of cigarettes smoked, but only two trials reported significant reductions in intervention groups. ^[1] Two trials reported elevated CO2 in the study group but without any pulmonary complications. ^[2] Two trials reported neurosensory outcomes of of surviving participants at two years of age. ^[3] Two trials reported the Cobb angle and vertebral body height (VBH), including 182 subjects without significant differences at the 12 mo follow-up (P > 0. ^[4] Two trials showed TTT to be more effective than usual care in terms of low disease activity (LDA), in some or all comparisons, whereas two trials reported little difference. ^[5] Two trials reported worse composite outcomes with restrictive triggers. ^[6] Two trials reported on readmission rate, but given the high heterogeneity, a meta-analysis was not realized. ^[7] Two trials reported improved clinical outcomes, measured as incidence of postoperative bleeding and symptomatic or cerebral vasospasm, while 3 saw no impact from omega-3 supplementation. ^[8] Two trials reported significant pain relief after a 2- to 3-month regimen with tongue protectors and showed no difference after aloe vera addition. ^[9]

Five Trials Reported

Five trials reported the outcomes of short-duration interventions, including 6-month and 9-week durations, and only 9-week treatment has a significant difference from the 12-month group (OR 0. ^[1] Five trials reported mortality at 28 days, one trial at 21 days, and one trial at 30 days. ^[2] Five trials reported that there were no serious adverse events. ^[3] Five trials reported the inclusion of intubated patients at baseline. ^[4] Among primary outcomes, five trials reported maternal anaemia, one trial reported preterm birth and three trials reported perinatal mortality. ^[5] The overall effect of HR for death of five trials reported had no statistically significant (HR=0. ^[6]

Three Trials Reported

Three trials reported improvement on sleep following foot reflexology, auricular plaster therapy, and exercise. ^[1] The purpose of the three trials reported here was to measure the efficiency of lysine utilization for growth and lysine requirement for maintenance of Nile tilapia (Oreochromis niloticus) during three growing stages. ^[2] Three trials reported on complete leg ulcer closure (isoxsuprine, arginine butyrate, RGD peptide matrix; very low quality of evidence). ^[3] Considering the individual trials, three trials reported the primary outcome of joint bleeding, and none showed a dfference between dosing regimens (low-certainty evidence). ^[4] Only three trials reported funding, with two funded by industry. ^[5]

Randomized Trials Reported

Two recent randomized trials reported seemingly contradicting clinical results with transcatheter edge-to-edge repair for patients with heart failure and severe secondary MR. ^[1] BACKGROUND Randomized trials reported no difference whether induction or expectant management is performed in non-diabetic women with large for gestational age babies but no tool has been validated for the prediction of high risk cases. ^[2] DATA SYNTHESIS Systemic reviews and meta-analyses of randomized trials reported azithromycin efficacy of 96% to 97% in genital chlamydia. ^[3] Two randomized trials reported no difference in mortality (RR = 0. ^[4]

Fmy Trials Reported

Only four trials reported measures of behaviour change, and the methods of data collection were susceptible to bias. ^[1] Four trials reported uptake data, of which three found low to medium uptake rates (3. ^[2] Four trials reported infections and impaired wound healing associated with steroids (n = 160. ^[3] Discussion: Only one of the four trials reported a positive effect direction, while the remaining studies reported negative or conflicting/unclear effects. ^[4]

Most Trials Reported

Most trials reported a sample size calculation (n=105, 71%). ^[1] Most trials reported one or more positive effects of stimulation on dysarthria-related abilities; however, given the overall high risk of bias and heterogeneity in participant, trial and outcome measurement characteristics, no conclusions can be drawn. ^[2] Most trials reported that intent-to-treat analysis and attrition rates were often high. ^[3]

Several Trials Reported

Background Several trials reported differential outcomes after percutaneous coronary intervention with drug‐eluting stents (DES) and coronary‐artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). ^[1] The study was suspended because of a refusal to participate and losses to follow up after several trials reported lack of effectiveness of hydroxychloroquine in hospitalized patients with COVID-19. ^[2] Several trials reported an improvement in oxygenation and respiratory rate during prone positioning, but impacts on clinical outcomes, particularly on intubation rates and survival, remain unclear. ^[3]

Both Trials Reported

Both trials reported that the most frequent adverse effects in patients treated with tirzepatide are mild to moderate gastrointestinal symptoms. ^[1] Both trials reported negative results, and the study by Currow and colleagues (5) is the largest and, arguably, best-quality trial on the topic conducted to date. ^[2] Both trials reported potentially concerning serious adverse events, particularly related to pulmonary complications. ^[3]

Seven Trials Reported

However, one trial found that drug therapies that reduce gastric acidity improved gastro-intestinal symptoms such as abdominal pain; seven trials reported significant improvement in measures of fat malabsorption; and two trials reported no significant improvement in nutritional status. ^[1] Results: Seven trials reported the application of patidegib. ^[2] Seven trials reported on health-related quality of life and symptom improvement using different methodologies. ^[3]

Completed Trials Reported

5%) completed trials reported results on the ClinicalTrials. ^[1] 2% of completed trials reported results by April 30, 2018. ^[2] 9% of completed trials reported registry results, with government and industry outperforming academic-sponsored trials. ^[3]

Few Trials Reported

Few trials reported on other eligible outcomes, and no studies reported on harms of screening or interventions. ^[1] Few trials reported a large effect size. ^[2] Few trials reported on safety, few trials were at an overall low risk of bias, and overall the quality of evidence was very low. ^[3]

19 Trials Reported

The latest network meta-analysis of pre-COVID-19 trials reported that treatment with non-invasive oxygenation strategies was associated with improved survival when compared with conventional oxygen therapy. ^[1] MAIN RESULTS We included 19 trials reported in 18 publications (5839 randomised participants): six trials compared penicillin with cephalosporins; six compared penicillin with macrolides; three compared penicillin with carbacephem; one compared penicillin with sulphonamides; one compared clindamycin with ampicillin; and one compared azithromycin with amoxicillin in children. ^[2]

Nine Trials Reported

Nine trials reported a significant percent LVEF increase and NYHA class decrease at 12 months after bone marrow and peripheral blood stem cells transplantation correlating with transplanted cells number. ^[1] Nine trials reported urinary incontinence severity outcomes enabling meta-analysis of transcutaneous electrical nerve stimulation (TENS; 5 trials) and electroacupuncture (4 trials). ^[2]

Vaccine Trials Reported

CONCLUSION As mRNA COVID-19 vaccine trials reported cases of Bell’s palsy as adverse events, we should pay attention to the occurrence of Bell’s palsy after inactivated COVID-19 vaccination. ^[1] Since both the Moderna and Pfizer Vaccine trials reported Bell’s Palsy as medically attended adverse events, the association between vaccine administration and onset of symptomatic Bell’s Palsy may warrant further investigation. ^[2]

Eligible Trials Reported

Eligible trials reported at least one of the outcomes including time to ipsilateral breast recurrence, overall survival and breast tissue related adverse events. ^[1] Thirty-one eligible trials reported on AF events (75 279 participants, mean age 62 years, 35. ^[2]

Eight Trials Reported

Eight trials reported PCR‐adjusted data to distinguish between new and recrudescent infection during the follow‐up period. ^[1] Twenty-eight trials reported a binary primary outcome. ^[2]

Efficacy Trials Reported

Published safety and efficacy trials reported high efficacy rates of 94-95 % after two interval doses, in conjunction with limited side effects and a low rate of adverse reactions. ^[1] Published safety and efficacy trials reported high efficacy rates of 94-95 % after two interval doses, in conjunction with limited side effects and a low rate of adverse reactions. ^[2]

Sponsored Trials Reported

BACKGROUND Although there is no drug-eluting stent (DES) approved by the FDA for the use in infrapopliteal arterial disease, several industry sponsored trials reported the outcome of the use of paclitaxel or sirolimus DES. ^[1] BACKGROUND Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. ^[2]

trials reported significant

The qualitative findings of the studies showed that major part of the included trials reported significant improvement in clinical periodontal parameters in periodontitis patients with the adjunctive use of probiotics compared with control group. ^[1] Most randomized controlled clinical trials reported significant benefits by diabetes self-management education (DSME) on DSM behaviors and metabolic control. ^[2] All six trials measured reduction in the number of cigarettes smoked, but only two trials reported significant reductions in intervention groups. ^[3] However, one trial found that drug therapies that reduce gastric acidity improved gastro-intestinal symptoms such as abdominal pain; seven trials reported significant improvement in measures of fat malabsorption; and two trials reported no significant improvement in nutritional status. ^[4] Recent trials reported significant reductions in all-cause mortality with single-inhaler triple therapy for chronic obstructive pulmonary disease (COPD). ^[5] At the time of approval, 8 (16%) trials reported significant improvement in OS. ^[6] Fifty-eight per cent of the trials reported significant differences in the results, and 30. ^[7] Two trials reported significant pain relief after a 2- to 3-month regimen with tongue protectors and showed no difference after aloe vera addition. ^[8]