Demonstrate the efficacy efficacy safety patient participation. Medical search. Frequent questions

Genentech, Inc. is sponsoring a study to evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamic effects of ocrelizumab in pediatric and adolescent patients with relapsing-remitting multiple sclerosis. (rarediseases.org)
Catalyst Pharmaceuticals is conducting a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety, tolerability and efficacy of amifampridine phosphate in patients with MuSK-MG. In addition, a sample of AChR-MG patients will be assessed for efficacy and safety of amifampridine phosphate. (rarediseases.org)
argenx BVBA is conducting a long-term, single-arm, open-label, multicenter phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients who have myasthenia gravis with generalized muscle weakness. (rarediseases.org)
While safety/tolerability was the primary endpoint of the trial, visual acuity, kinetic visual field, and functional vision changes were also assessed. (kiorapharma.com)
The Phase 2a proof-of-concept trial was a two-week, randomized, double-blind, placebo-controlled multi-center study assessing the safety, tolerability and efficacy of a single IV administration of PCN-101. (atai.life)
The Phase 2a proof-of-concept trial was a randomized, double-blind, placebo-controlled multi-center study assessing the safety, tolerability and efficacy of IV PCN-101 (R-ketamine) in 102 patients with TRD across three arms. (atai.life)
Primary endpoints included safety and tolerability for phase 1, and objective response rate for phase 2. (elsevierpure.com)
Eight-five percent of all respondents (100% of pain physicians) indicated that they recommended OTC topical analgesics to patients and 81.5% said they had no concerns about the safety and tolerability of such products. (ommegaonline.org)
Both short and long-term use of many pharmacotherapeutic regimens has been associated with safety issues, tolerability, and, in the case of opioids, tolerance, hyperalgesia, and misuse [6-8] . (ommegaonline.org)

NORD shares information about opportunities to participate in clinical trials and other studies so that patients and their physicians may decide whether specific studies are appropriate for them. (rarediseases.org)
We do not endorse or recommend participation in any specific clinical trials or studies. (rarediseases.org)
Despite the fact that larger trials were halted early, what my colleagues and I were seeing as we continued to follow patients from our initial trials was that over time, they were getting better, and not only that, they were staying better. (scitechdaily.com)
Some of the questions that have been asked by more than 120 health professionals, researchers and managers of hospitals and public and private centers that have participated this Thursday in Madrid, together with representatives of pharmaceutical companies that promote trials, in a work meeting organized by Farmaindustria to advance the excellence of clinical research in Spain, the phase of development that serves to demonstrate the efficacy and safety of new medicines. (distefar.com)
In this line, the meeting discussed the latest data and future prospects of the BEST Project of excellence in clinical research, promoted by Farmaindustria to promote trials in Spain, as well as areas for improvement in the field of patient recruitment, one of the aspects where there is a greater capacity for progression in Spain. (distefar.com)
In its twelve years of life, the BEST Project has facilitated the completion of more than 3,000 trials, involving 150,000 patients. (distefar.com)
At any given time, Montefiore is actively recruiting patients for dozens of cardiac trials, including three new studies that began in 2011. (montefiore.org)
The results of preclinical trials have demonstrated efficacy and non-toxicity of this drug. (almazovcentre.ru)
March 12, 2021 cbdnews Marijuana Health Benefits Comments Off on Delta 8 THC Benefits - Research, Science, Clinical Trials Delta 8 THC Benefits - Research, Science, Clinical Trials Read full article: Buy Delta 8 The only well established means to confirm a compound's safety account is through professional and randomized regulated trials. (stradanove.net)
Clinical trials have shown the efficacy and safety of pregabalin at dosages ranging from 150 to 600 mg/day in patients 18 years of age with painful DPN or PHN91011121314151617. (stradanove.net)
20]. Several randomized trials attest to the 2020, depression is expected to become efficacy and safety of CBT in the treatment the single leading cause of disease burden of depression in children and adolescents worldwide [3]. (who.int)
The survey also explored reasons for more complexity in clinical trials, as well as the state of patient recruitment and site selection. (appliedclinicaltrialsonline.com)
And the increased insights FHIR brings can inform better trial designs, more streamlined processes for randomized, pragmatic and observational trials, and better awareness of protocol execution at the site and the effects of new drug and device introduction on patients. (appliedclinicaltrialsonline.com)
The results published today in Clinical Trials: Journal of the Society of Clinical Trials demonstrate that using real world diseases epidemiology data, rather than the traditional benchmark of US Census Bureau race and ethnicity data, would ensure clinical trial enrolment reflects the populations affected by different diseases. (gsk.com)
GSK is committed to ensuring our clinical trials reflect the diverse demographics of the patients impacted by the disease under study, given the disproportional impact some diseases may have on specific patient groups. (gsk.com)
To make meaningful progress on diverse participation in clinical trials, we need meaningful collaboration with regulators, patients, academia, other biopharma companies and the wider healthcare ecosystem so that together we can achieve a shared goal of better health outcomes for all. (gsk.com)
Clinical trials are scientific studies in which new treatments -drugs, diagnostic or medical procedures, and other therapies - are tested to determine if they are safe and effective for use with patients. (baptistonline.org)
These trials help scientists answer questions about new therapies or devices, including what diseases they should be used for, what doses are most effective, and which patients can benefit most. (baptistonline.org)
Clinical efficacy was evident in three pivotal phase III trials with axitinib-pembrolizumab, cabozantinib-nivolumab, and lenvatinib-pembrolizumab combinations. (bvsalud.org)
To optimise these combination therapies while preserving patient quality of life, escalation and de-escalation strategies are being evaluated in prospective randomised trials, based on patient selection according to their prognosis risk. (bvsalud.org)
The MIRA trial (M1095-HS-201), which recruited 234 patients, is the first randomized, double-blind, placebo-controlled trial to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint, a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, therefore representing a landmark milestone in HS clinical development. (pipelinereview.com)
Methods: We searched relevant databases for all randomized controlled trials that reported the efficacy and or safety ofany anti-infective drugs published up to April 30, 2022 for different outcomes. (bvsalud.org)

While we are especially excited about the statistically significant improvements in IGA and EASI scores, which were remarkably achieved in an overwhelmingly mild population of just 41 patients and in just four weeks, we are also very encouraged by the rapid reduction in itch and the unique aspects of skin microbiome control to manage AD flare-ups that are primarily caused by bacteria. (fxtribune.com)
The results showed the treatment resulted in statistically significant and clinically meaningful improvements in overall survival for patients with mCRC who had previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. (outsourcing-pharma.com)
The results from the trial , which were published in the New England Journal of Medicine in May 2023, demonstrated that the combination of Lonsurf plus bevacizumab provided statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to Lonsurf alone. (outsourcing-pharma.com)
This was the first phase 3 study against an active control in third-line mCRC that demonstrated statistically significant efficacy and safety. (outsourcing-pharma.com)
OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced late-breaking data from the Phase 3 GRAPHITE study presented at the 2023 Tandem Meetings, demonstrating vedolizumab achieved a statistically significant and clinically meaningful improvement in lower gastrointestinal (GI) aGvHD-free survival by Day 180 after allo-HSCT with no relevant differences in safety profile versus placebo. (businesswire.com)

Our objective was to assess the efficacy of chemotherapy re-challenge after ICI, compared with second-line chemotherapy without previous ICI in patients with locally advanced or metastatic urothelial carcinoma (la/mUC). (bvsalud.org)

Safety will be the primary focus for the initial 24 weeks after treatment (primary study period) and study participants will continue to be assessed (safety and efficacy) for up to a total of 104 weeks following treatment with RGX-111. (rarediseases.org)
Three-quarters of all participants met the treatment response criterion for more than half of their participation in the study, with 21 percent of all participants demonstrating continuous response to treatment from the first year forward. (scitechdaily.com)
Of 28 participants, 14 completed at least eight years of follow-up, 11 others completed at least four years, and three dropped out prior to eight years of participation. (scitechdaily.com)
Research is experimental - participation in research may or may not benefit individual participants or patients. (baptistonline.org)
In fact, the sole act of participating in a research study has been demonstrated to improve health outcomes for individual research participants and patients alike. (acrpnet.org)
Findings In this phase 2 randomized clinical trial of 91 patients with endocrine-resistant, metastatic breast cancer who were previously treated with a cyclin-dependent kinase 4/6 inhibitor, participants were randomized to receive treatment with alisertib alone or combined with fulvestrant. (kanker-actueel.nl)
Participants were purposively selected on the basis of their knowledge and participation in the establishment and activities of Ruvheneko Programme. (bvsalud.org)

By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients. (atai.life)
Conclusion: Inhibition of JAK1 with INCB052793 (monotherapy or combination therapy) or itacitinib plus azacitidine did not demonstrate clinically meaningful responses in these patients with hematopoietic malignancies. (elsevierpure.com)

Encinitas, California--(Newsfile Corp. - November 4, 2023) - Kiora Pharmaceuticals (NASDAQ: KPRX) today announced topline results of a Phase I/II clinical trial demonstrating proof-of-concept that KIO-301 , the company's first-in-class small molecule, has the potential to meaningfully improve vision in patients with Retinitis Pigmentosa (RP) who are living with ultra-low vision or complete blindness. (kiorapharma.com)
Looking ahead, our team is focused on executing and advancing our clinical stage CD19 targeted CAR T programs and providing a clinical update in late Q4 2022 or early Q1 2023, depending on patient accrual and follow-up. (biospace.com)
Precision expects to provide an update in late Q4 2022 or early Q1 2023, depending on patient accrual and follow-up, on its two distinct CD19 targeted products, including azer-cel which is aiming to achieve a potential first-in-class allogeneic CAR T therapy in the CAR T relapsed population, and PBCAR19B which is seeking to displace autologous CAR T in the second/third line DLBCL population. (biospace.com)
On July 31, this year (2023), Servier, which conducted the trial with Taiho Oncology, received approval from the European Commission for Lonsurf in combination with bevacizumab for the treatment of adult patients with mCRC who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. (outsourcing-pharma.com)

Each patient's participation in the study will last 1.5 years, with a 6-month randomized placebo-controlled trial (RCT) period followed by a 12-month open-label extended treatment period. (ifopa.org)
The Phase 3, randomized, double-blind, placebo-controlled, multicenter GRAPHITE study evaluated the efficacy and safety of vedolizumab as prophylaxis for intestinal aGvHD in patients undergoing allo-HSCT from unrelated donors for the treatment of hematological malignancies. (businesswire.com)

PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint. (atai.life)
Patients were assessed for a change in depressive symptomatology using the Montgomery-Åsberg Depression Rating Scale (MADRS) at intervals over 14 days, with the primary endpoint at 24 hours post-dose. (atai.life)
The trial met its primary endpoint with a significantly greater proportion of patients treated with both sonelokimab 120mg and 240mg achieving HiSCR75 compared to those on placebo at week 12. (pipelinereview.com)

The randomized, double-blind, vehicle-controlled trial evaluated the safety and efficacy of AB-101a, a topical hydrogel using Alphyn's proprietary AB-101 multi-target therapeutic platform, in 41 patients from seven centers over four weeks. (fxtribune.com)
Randomization resulted in 81% participation of patients with mild AD, a study population in which it is difficult to demonstrate improvement resulting from a therapeutic intervention. (fxtribune.com)
Our aim is to focus on programs in which ARCUS is most differentiated and where we see potential for a clear and rapid path to market, while providing a potentially curative therapeutic solution to patients with the highest unmet need. (biospace.com)
Precision continues dosing subjects with optimized azer-cel CAR T cells in the CAR T relapsed population in which it has shown high and durable complete response rates, while further reducing the dose of lymphodepletion to standard levels in pursuit of best therapeutic index for this patient population. (biospace.com)
Specific treatments are still lacking for AHC and currently, therapeutic strategies for symptomatic relief or preventing the recurrence of paroxysmal phenomena are only available but with relative efficacy. (iahcrc.net)
From Taiho Pharmaceutical's initial discovery of Lonsurf to this latest regulatory milestone, we are appreciative of the investigators and patients who helped to contribute to our growing body of knowledge of this important therapeutic through their participation in our clinical development programs," said Fabio Benedetti, MD, global chief medical officer for oncology, Taiho Pharmaceutical Co., Ltd. (outsourcing-pharma.com)
This leaves many pain patients with limited therapeutic options and inadequate pain control [14,15] . (ommegaonline.org)
Finally, new therapeutic approaches, such as targeting hypoxia-inducible factor (HIF) and the development of innovative treatments using antibody-drug conjugates (ADCs), CAR-T cells, or radiopharmaceuticals, are all potential candidates to improve further patient survival. (bvsalud.org)
Since pharmaceutical interest in this disease is low, two EU-supported projects (EURAMAN and HUE-MAN) within the 5th and 6th framework program, respectively have worked towards developing the recombinant human enzyme (rhLAMAN) as a therapeutic agent for patients suffering from alpha-Mannosidosis. (europa.eu)
In line with our plans we have been able to demonstrate the safety and clinical efficacy of rhLAMAN as an effective therapeutic agent for treatment of the human disease alpha-Mannosidosis in clinical trial Phases 1 and 2. (europa.eu)
4 In light of current therapeutic uncertainty, the large proportion of patients requiring second-line therapy over time 3 , 6 and the increasing prevalence of type 2 diabetes, 7 the utilization and cost of second-line therapy are likely to continue to grow. (cmaj.ca)

In preclinical (animal) studies, saracatinib demonstrated potency for the drug to suppress of heterotopic ossification (HO) or bone formation in FOP animal models. (ifopa.org)

Moreover, cancer patients are often elderly and have comorbidities, and cancer therapies frequently employ immunosuppressive agents. (springer.com)
however, for the large majority of patients lacking access to advanced therapies stroke mortality and residual morbidity remain high and many patients become incapacitated by motor and cognitive deficits, with loss of independence in activities of daily living. (mdpi.com)
Unfortunately, it may be an insidious condition, since approximately one-third of patients affected by AF, often paroxysmal, are asymptomatic [ 2 , 3 ] and a missed AF diagnosis means no access to effective stroke prevention therapies using oral anticoagulation. (hindawi.com)
Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced positive top-line results from its global Phase 2 MIRA trial evaluating the efficacy and safety of the Nanobody ® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). (pipelinereview.com)
4) If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Screening Visit and be willing to remain on a stable dose and regimen for the duration of the trial. (who.int)

REGENXBIO Inc. is conducting a phase I, first-in-human, multicenter, open-label, dose escalation study of RGX-111 gene therapy in patients with MPS I. Two, one time doses of RGX-111 will be studied in approximately 5 patients age 6 years or older. (rarediseases.org)
We thank all the patients, families, caregivers, and investigators for their support and participation in the PCN-101 Phase 2a trial," said Florian Brand, CEO and Co-Founder of atai. (atai.life)
The second study is a Phase III trial called INOVATE-HF, which is aimed at demonstrating the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with heart failure. (montefiore.org)
Within the framework of the memorandum on cooperation, the specialists of the Research Laboratory use the hyperinsulinemic-euglycemic clamps (phase 1 study) in patients with type 1 DM and healthy volunteers using domestic biosimilar insulins of various durations. (almazovcentre.ru)
Precision continues to recruit patients at Dose Level 2 (flat dose of 540 million cells) with the intent to complete the Phase 1 dose escalation. (biospace.com)
After a pilot phase as an OBSERV-AHC sub-study, the KETO-AHC Study has just been launched as an official IAHCRC Study, about the efficacy of ketogenic diet in AHC and an article about the results of the pilot study about the efficacy of CBD ( CBD-AHC Study ) is in preparation for publication. (iahcrc.net)
Our Phase 3 study in the prevention of lower GI aGvHD is the latest example of Takeda's commitment to advancing the science of vedolizumab, furthering the understanding of its mechanism of action, and exploring new ways to help patients. (businesswire.com)
Patients and Methods: This phase 1/2 study evaluated 2 oral, novel JAK1 inhibitors (INCB052793 and itacitinib) in advanced hematologic malignancies. (elsevierpure.com)
Two patients with DNMTi-refractory disease had an objective response in phase 2. (elsevierpure.com)
5. TTFields - Large-scale, phase III clinical studies have validated the safety and efficacy of TTFields in patients with recurrent and newly diagnosed glioblastoma6,8. (orlandohealth.com)
6. Lomustine-TMZ as maintenance therapy might improve survival in newly diagnosed patients compared to maintenance TMZ alone, as suggested by an open-label phase 3 trial in 141 patients, which demonstrated a HR of 0.6 (95% CI 0.35-1.03, p=0.0492) for the combined treatment9. (orlandohealth.com)

We are pleased to be part of this global study and provide an innovative treatment to our pediatric patients who are suffering from this condition here in South Florida," Dr. Latson said. (jdch.com)
Liraglutide, a glucagonlike peptide-1 (GLP-1) agonist, is the first noninsulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. (medscape.com)

Metformin is widely accepted as first-line pharmacotherapy for patients with type 2 diabetes mellitus when glycemic control cannot be achieved by lifestyle interventions alone. (cmaj.ca)

A study to be published online on Friday, October 4, 2019, in the American Journal of Psychiatry found that deep brain stimulation (DBS) of an area in the brain called the subcallosal cingulate (SCC) provides a robust antidepressant effect that is sustained over a long period of time in patients with treatment-resistant depression-the most severely depressed patients who have not responded to other treatments. (scitechdaily.com)
Dr. Mayberg led the first trial of DBS of the subcallosal cingulate white matter, known as Brodmann Area 25, for treatment-resistant depression patients in 2005, demonstrating that it could have clinical benefit. (scitechdaily.com)
Given that patients with treatment-resistant depression are highly susceptible to recurrent depressive episodes, the ability of DBS to support long-term maintenance of antidepressant response and prevention of relapse is a treatment advance that can mean the difference between getting on with your life or always looking over your shoulder for your next debilitating depressive episode. (scitechdaily.com)
Specifically, the study documents the long-term outcome data (4-8 years) for 28 patients who were enrolled in an open-label clinical trial of SCC DBS for treatment-resistant depression. (scitechdaily.com)
Data presented through this study support the long-term safety and sustained efficacy of SCC DBS for treatment-resistant depression. (scitechdaily.com)
Joe DiMaggio Children's Hospital recently announced the successful treatment of a patient with atrial septal defects (ASD), or opening defect in the wall of the heart that separates the top two chambers of the heart, using the first transcatheter ASD occluder with a metal-free frame. (jdch.com)
To inform and educate specialty and managed care pharmacists about the use of PARP inhibitors in ovarian cancer, their differences and similarities, evidence to ensure appropriate access to treatment and strategies to ensure effective patient care thus leading to optimized outcomes. (powerpak.com)
These patients - all of whom had previously failed at least two rounds of antidepressants - received a single IV dose of either placebo, 30 mg, or 60 mg of PCN-101 adjunctively to their existing treatment regimen. (atai.life)
The Centre has all the facilities for advanced examination and comprehensive treatment of patients with parathyroid gland disease. (almazovcentre.ru)
We are also exploring the potential of our immune-evading stealth cell technology with PBCAR19B in earlier line DLBCL patients with the goal of displacing autologous CAR T treatment options. (biospace.com)
The IAHCRC E-Diary could be also used in clinical practice, to monitor the course of AHC spells in patients and adjust their treatment accordingly, and its model could be potentially adopted for other rare and complex disorders. (iahcrc.net)
Baseline and two-years follow up data have been collected in the Platform for more than 120 patients by the participating centers in the US and in Europe, about paroxysmal and non-paroxysmal features, about neuropsychological and behavioural features, about treatment and genetics. (iahcrc.net)
Saracatinib, also known as AZD0530, is an investigational drug that was initially developed as a potential treatment for patients with cancer. (ifopa.org)
The study objective is to evaluate the efficacy and safety of posterior foraminotomy in comparison to anterior foraminotomy with fusion for the treatment of spondylotic foraminal stenosis. (biomedcentral.com)
Despite adequate conservative non-operative therapy, a large number of patients will require surgical treatment. (biomedcentral.com)
He said: "The FDA approval of this combination provides patients with mCRC an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population. (outsourcing-pharma.com)
Timothy Whitten, president and CEO at Taiho Technology Inc, said: "The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason - approximately 22% of patients with colorectal cancer in the U.S. are diagnosed after the cancer has metastasized. (outsourcing-pharma.com)
And now we look forward to supporting healthcare professionals in the treatment of patients with mCRC who may become candidates for treatment with LONSURF in combination with bevacizumab. (outsourcing-pharma.com)
1 Intestinal aGvHD is a serious complication characterized by inflammation of the GI tract which can affect patients undergoing allo-HSCT, a common treatment for blood cancers. (businesswire.com)
Treatment-related adverse events were reported in 24.8% versus 28.4%, and treatment related serious adverse events in 8.5% versus 6.5% of patients treated with placebo versus vedolizumab, respectively. (businesswire.com)
Effective prevention of aGvHD, especially with lower intestinal involvement, has been an important treatment goal for physicians when patients are undergoing allo-HSCT. (businesswire.com)
1 The study enrolled 333 patients who were randomly assigned in a 1:1 ratio to one of two treatment groups receiving either an intravenous infusion of vedolizumab 300 mg or placebo on days -1 (before allo-HSCT), and on days +13, +41, +69, +97, +125, and +153 following allo-HSCT, alongside a background GvHD prophylaxis regimen. (businesswire.com)
Results: Fifty-eight patients were enrolled, all received study treatment and discontinued either treatment or participation in the study. (elsevierpure.com)
Surgical resection - Treatment of patients with GBM usually consists of tumor resection (to the extent safely feasible) or diagnostic biopsy. (orlandohealth.com)
To determine if TTFields treatment at 200 kHz to the brain concomitantly with RT and TMZ in the treatment of GBM patients prolongs the overall survival of patients, compared to RT and TMZ treatments followed by TTFields and maintenance TMZ. (orlandohealth.com)
This nonrandomized controlled trial ancillary study evaluates the survival outcomes associated with corticosteroid use during nivolumab treatment for patients with metastatic renal cell carcinoma. (bvsalud.org)
To date, no biomarker facilitating the selection of an optimal treatment by disease and patient status has been reported. (bvsalud.org)
This study aims to compare the safety and efficacy of stent-assisted coiling (SAC) with those of coiling alone (CA) for the treatment of ruptured tiny intracranial aneurysms. (frontiersin.org)
The safety and efficacy of SAC in the treatment of ruptured tiny intracranial aneurysms need to be further investigated. (frontiersin.org)
Well-designed and effectively implemented clinical pathways can support the delivery of evidence-based cancer care, while enhancing communication and education between a patient and his or her physician on the complex details of a treatment plan," said ASCO President Daniel F. Hayes, MD, FACP, FASCO . (ascopost.com)
The final goal of ALPHA-MAN was to make a future treatment for ALL alpha-Mannosidosis patients available and thereby dramatically improving their life expectancy and quality of life. (europa.eu)
The high performance of the Nanobody ® at 120mg, the dose found to be optimal in psoriasis, demonstrates the advantage of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases. (pipelinereview.com)
3 Multiple second-line treatment strategies are available for patients in whom glycemic control has become inadequate. (cmaj.ca)
8 As part of a larger initiative to determine optimal prescribing of antihyperglycemic agents, we sought to determine the incremental cost-effectiveness of treatment with alternative second-line agents added to metformin in patients with type 2 diabetes no longer adequately controlled by metformin monotherapy. (cmaj.ca)
Question Does treatment with alisertib restore fulvestrant sensitivity and improve tumor objective response rates (ORRs) compared with alisertib monotherapy in patients with endocrine-resistant metastatic breast cancer? (kanker-actueel.nl)
3) Patient has access to and ability to use conventional on-demand treatment for HAE attacks. (who.int)
Information was collected through record drugs [ 6 ], ability to ensure compliance review and patient interviews in 43 facili- with treatment and financial incentives. (who.int)
The guidelines recommend insulin treatment in all patients who present with ketosis or extremely high blood glucose levels because it may not be clear initially whether these patients have type 2 or type 1 diabetes. (medscape.com)
Fingerstick self-glucose monitoring is recommended for all patients receiving insulin or sulfonylureas, those starting or changing therapy, and those who have not met treatment goals or who have intercurrent illness. (medscape.com)
Unless an acute complication (eg, recurrent hypoglycemia, persistent ketosis, hyperglycemic hyperosmolar state) occurs or there is poor patient compliance with treatment, type 2 diabetes is usually managed in an outpatient setting. (medscape.com)
The state of knowledge regarding the treatment of patients potentially exposed to hazardous substances in the environment is constantly evolving and is often uncertain. (cdc.gov)
This monograph is intended as an educational resource for physicians and other health professionals in assessing the condition and managing the treatment of patients potentially exposed to hazardous substances. (cdc.gov)

The objective was to assess the extent to which pain specialists were aware of topical analgesics and how often and under what circumstances they recommended topical pain relievers to their patients to help control painful symptoms. (ommegaonline.org)

METHODS: In this multicentre retrospective study, we included all patients with la/mUC initiating second or third-line chemotherapy from January 2015 to June 2020. (bvsalud.org)

Eligible patients will be titrated to an efficacious dose of amifampridine phosphate and those who demonstrate improvement will be randomized to either placebo or amifampridine, in a double-blind fashion, for 10 days. (rarediseases.org)
However, the single 60mg dose of PCN-101 showed an efficacy signal at each timepoint over the 2-week timeframe of the study. (atai.life)
An abstract on the cell dose and functional attributes of azer-cel that may be associated with positive safety and efficacy results for CAR T therapy in R/R B-cell lymphoma was accepted for poster presentation at the 64th ASH Annual Meeting taking place December 10-13, 2022. (biospace.com)
5) Patients last dose of attenuated androgens was at least 28 days prior to randomization. (who.int)
The difference between the usual effective dose and the dose that causes severe or life-threatening side effects is called the margin of safety. (msdmanuals.com)

It's our job to make sure these promising developments are translated into meaningful products that can make a difference for patients and consumers. (fda.gov)

Our primary objective was to describe design characteristics and outcomes of studies testing the efficacy of pregabalin in behavioral models of pain. (iasp-pain.org)
We queried MEDLINE, Embase, and BIOSIS to identify all animal studies testing the efficacy of pregabalin published before January 2018 and recorded experimental design elements addressing threats to validity and all necessary data for calculating effect sizes, expressed as the percentage of maximum possible effect. (iasp-pain.org)
We identified 204 studies (531 experiments) assessing the efficacy of pregabalin in behavioral models of pain. (iasp-pain.org)
The analgesic effect of pregabalin was consistently robust across every etiology/measure tested, even for pain conditions that have not responded to pregabalin in patients. (iasp-pain.org)

Janssen Research & Development is sponsoring an open-label, uncontrolled, multicenter study to evaluate the pharmacokinetics, pharmacodynamics, safety, and efficacy of nipocalimab in treating children between the ages of two and eighteen years old with generalized myasthenia gravis. (rarediseases.org)

Until an effective vaccine becomes available for widespread use, it is imperative that surgical oncologists remain focused on providing optimal care for our cancer patients while managing the demands that the COVID-19 pandemic will continue to impose on all of us. (springer.com)
However, uncertainty exists regarding the optimal second-line therapy for patients whose diabetes is inadequately controlled by metformin monotherapy. (cmaj.ca)

The results will inform how GSK and potentially other clinical trial sponsors can better design research to represent the diversity of real-world patient populations, given that some diseases disproportionately impact certain racial and ethnic groups. (gsk.com)
1} However, the benefits rendered from research results and participation are limited to the groups and sometimes communities that are represented in the research setting, leaving underrepresented groups less likely to benefit clinically. (acrpnet.org)
RESULTS: Overall, 553 patients were included. (bvsalud.org)
In humans, LAMAN deficiency results in progressive mental retardation, skeletal changes, hearing loss and recurrent infections and many patients die during early childhood. (europa.eu)
Meaning The trial results found that while alisertib did not restore fulvestrant sensitivity and increase ORRs, promising clinical activity was observed with alisertib monotherapy among patients with endocrine-resistant and cyclin-dependent kinase 4/6 inhibitor-resistant metastatic breast cancer. (kanker-actueel.nl)

International patient clinical studies questions. (stradanove.net)
Its efficacy and safety have been demonstrated in several clinical studies, making it a viable option for many suffering from venous insufficiency. (whatscookingwithdoc.com)

It has demonstrated a long-term safety but partial effectiveness. (iahcrc.net)
By conducting research, we explore treatments and address questions about the ways in which treatments are being conducted, the efficacy of current and proposed medical devices, and the effectiveness and side effects of medications. (baptistonline.org)
are demonstrating the effectiveness and safety of the drug. (msdmanuals.com)

Regeneron Pharmaceuticals is sponsoring a study to evaluate the effect of pozelimab and cemdisiran on daily functioning in patients with symptomatic generalized myasthenia gravis. (rarediseases.org)
This was a double-blind, randomized, controlled trial conducted in 84 symptomatic knee osteoarthritis patients. (biomedcentral.com)
The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. (biomedcentral.com)
Both 10 mg and 40 mg of TA significantly improved pain and quality of life in patients with symptomatic knee OA. (biomedcentral.com)
Insulin therapy is indicated in symptomatic patients with persistent hyperglycemia, the presence of an HbA 1c of more than 9%, or ketoacidosis. (medscape.com)

The procedure is typically performed in an outpatient setting and patients can usually return to normal activities right after, with minimal discomfort. (whatscookingwithdoc.com)

Functional MRI demonstrated a qualitative increase in brain activity in the primary visual cortex at days 2 and 14 post-injection compared to baseline. (kiorapharma.com)
Key secondary endpoints included a proportion of patients defined as responders, meaning patients who experienced 50% improvement from baseline in MADRS, and a proportion of patients in remission, defined as a total MADRS score of less than 10. (atai.life)

Using generic medications for chronic diseases provides efficacy similar to that of brand-name medication use, but at a lower price, potentially enhancing adherence. (cdc.gov)

We spend a lot of time with patients, explaining the benefits-both intrinsic and extrinsic-that are associated with their participation in a clinical trial," adds Roger Swayze, RN, BSN, MBA, Director, Clinical and Regulatory Affairs, Department of Cardiovascular and Thoracic Surgery and Department of Surgery. (montefiore.org)
Alphyn's AB-101 platform has multiple bioactive compounds and therefore multiple mechanisms of action to support a robust portfolio of dermatology therapeutics that have potential safety, efficacy, and regulatory marketing clearance advantages. (fxtribune.com)
I would like to acknowledge the Global Coalition for Regulatory Science Research (GCRSR), co-chaired by William Slikker, head of FDA's National Center for Toxicological Research and Marta Hugas, of the European Safety Authority for co-hosting this conference. (fda.gov)
Each of the regulatory agencies gathered here share critical responsibilities in their own countries for the oversight of drug and food safety. (fda.gov)
It examined the range of activities, from optimization of a lead compound through to regulatory review of the safety, efficacy and quality of a new product, and identified several key issues that need careful consideration. (who.int)

CDC's evidence-based guidelines for health care are designed to protect healthcare workers and patients, encourage safe practices, improve health outcomes, and save lives. (cdc.gov)

For most patients with type 2 diabetes that is inadequately controlled with metformin monotherapy, the addition of a sulphonylurea represents the most cost-effective second-line therapy. (cmaj.ca)

The novel device has been implanted as part of the ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial , which will evaluate the safety and efficacy of the transcatheter reSept ASD Occluder in patients with clinically significant secundum ASDs. (jdch.com)
The study aims to demonstrate the safety and efficacy of the reSept™ ASD Occluder for treating clinically significant secundum ASD with a transcatheter approach as compared to pre-defined performance goals from other commercially available occluder devices. (jdch.com)
The clinical outcomes at discharge and follow-up between the two groups demonstrated no significant differences ( P = 0.192 and P = 0.085, respectively). (frontiersin.org)

Under the direction of Co-Principal Investigators, Drs. Casson (University of Adelaide, Department of Ophthalmology) and Van Gelder, the ABACUS trial included 6 patients who were administered KIO-301 in each eye for a total of 12 eyes assessed. (kiorapharma.com)

This robust and affordable RITMIA™ technology could be used to conduct population-wide screening in patients at risk for silent AF, thanks to the long-term monitoring applicability. (hindawi.com)
5 Inpatient research has been more robust, with patient involvement credited with improving rates of both readmission for heart failure and hand washing by staff. (aafp.org)

1 In addition, no relevant differences in safety profile between the vedolizumab and placebo arms were observed, and no new safety signals were identified. (businesswire.com)

and integrate house staff into multidisciplinary team-based safety initiatives as a national priority. (wikipedia.org)
Recent studies demonstrating the value of multidisciplinary hand-hygiene promotion programs and the potential role of alcohol-based hand rubs in improving hand-hygiene practices are summarized. (cdc.gov)
The panel provides perspectives on: (1) creating a safe environment for surgical oncology care, (2) redirecting the multidisciplinary model to guide surgical decisions, (3) harnessing telemedicine to accommodate requisite physical distancing, (4) understanding interactions between SARS CoV-2 and cancer therapy, (5) considering the ethical impact of professional guidelines for surgery prioritization, and (6) advocating for our patients who require oncologic surgery in the midst of the COVID-19 pandemic. (springer.com)

The Alliance of Independent Academic Medical Centers (AIAMC) is an American national membership organization of approximately 70 major academic medical centers and health systems committed to quality patient care, medical education and research. (wikipedia.org)
In early 2007, the Alliance of Independent Academic Medical Centers (AIAMC) launched Improving Patient Care through Graduate Medical Education: A National Initiative of Independent Academic Medical Centers. (wikipedia.org)
These are distinct from "community advisory boards," which are often patient-dominated clinic boards of directors required for all Federally Qualified Health Centers (FQHCs). (aafp.org)

Current ASD occluders have metallic frames that could place patients at risk for complications associated with long-term presence of metal in the heart and may limit future transseptal interventions. (jdch.com)
Precise prediction of HRQOL changes after rehabilitation interventions is critical for optimizing stroke rehabilitation efficiency and efficacy. (springer.com)
To improve patients' HRQOL, healthcare professionals have to provide rehabilitation interventions that are most effective for each patient based on his/her responses to that rehabilitation therapy. (springer.com)
Building accurate prediction models for forecasting patients' HRQOL improvements after rehabilitation interventions and identifying predictors relevant for HRQOL improvements in stroke patients are thus imperative for providing insights to healthcare professionals on making accurate clinical decision. (springer.com)

Burn patients should be systematically evaluated using the methodology of the American College of Surgeons Advanced Trauma Life Support course. (medscape.com)
Is there an established methodology for prioritizing efficacy, safety, and cost? (ascopost.com)

Celgene is conducting a clinical trial of fedratinib in patients with DIPSS (dynamic international prognostic scoring system)-intermediate or high- risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with Ruxolitinib to evaluate the percentage of patients with at least a 35% reduction of spleen volume and to evaluate the safety of fedratinib. (rarediseases.org)
As previously reported, the trial met all primary and secondary endpoints with minimal safety and side effects. (fxtribune.com)
Pediatricians and primary care providers (PCPs) are often the first point-of-contact for patients with AD. (fcaap.org)
Medical care's primary aim is to treat our patients to improve their health and well-being using proved and effective treatments. (baptistonline.org)
[ 16 ] As described by the American College of Surgeons Committee on Trauma, evaluation of the burn patient is organized into a primary survey and secondary survey. (medscape.com)
The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection. (uclahealth.org)
Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. (medscape.com)
The goal of Case Studies in Environmental Med icine (CSEM) is to increase the primary care provider's knowledge of hazardous substances in the environment and to help in evaluation and treating of potentially exposed patients. (cdc.gov)

records that can be easily accessed by patient-focused apps and their authorized caregivers through APIs. (appliedclinicaltrialsonline.com)
A patient advisory council, also known as a "patient advisory board" or a "patient and family advisory council," is a representative group of patients and caregivers who meet regularly with clinic staff to help improve clinic performance. (aafp.org)

Supraphysiological doses of vitamin D have been shown to have a positive effect on the indicators of microcirculation and inflammation in patients with type 2 diabetes and diabetic neuropathy. (almazovcentre.ru)

As a result of these efforts, AIAMC has initial findings that demonstrate the efficacy of integrating GME into patient safety and quality improvement initiatives. (wikipedia.org)
Initial clinical experience demonstrates effective closure of the ASDs treated with the novel investigational device 1 . (jdch.com)

Lower GI aGvHD represents a critical unmet need in patients undergoing allo-HSCT," said Yi-Bin Chen, MD, Director, Hematopoietic Cell Transplant & Cell Therapy Program, Mass General Cancer Center. (businesswire.com)

Although IA corticosteroids demonstrated efficacies in relieving pain in knee OA which allows patients to utilize the joints with minimal pain, there is an ongoing concern about the cartilage safety and long-term OA progression. (biomedcentral.com)

It is incredibly exciting to have the participation of Joe DiMaggio Children's Hospital to this important pivotal trial," said Laurent Grandidier, CEO of atHeart Medical. (jdch.com)

GSK is working with patient advocacy groups and academic organisations to tackle the barriers that negatively impact clinical trial turnout of certain patient populations, such as access to transportation, language differences, lack of trust and awareness. (gsk.com)
Page 2 of 8 physicians about generics and comfort with generic substitution significantly increased generic use, demonstrating that such barriers could be overcome (9,10). (cdc.gov)

This series will address these educational gaps among PCPs and pediatricians, and application of the knowledge gained will improve outcomes for patients with AD. (fcaap.org)

Previous studies have demonstrated that there is an incremental diagnostic yield by prolonging monitoring period for the detection of AF, and this holds true up to few years of monitoring duration [ 8 , 9 ]. (hindawi.com)

The long-term data presented in this study, conducted at Emory University and led by Helen S. Mayberg, MD, now Professor of Neurology, Neurosurgery, Psychiatry, and Neuroscience, and Founding Director of the Nash Family Center for Advanced Circuit Therapeutics at the Icahn School of Medicine at Mount Sinai, validates earlier work conducted by the research team and lays the foundation for additional studies to refine and optimize DBS for these patients. (scitechdaily.com)
In addition to the objective data, patients reported positive changes in their vision over the course of the 28-day study. (kiorapharma.com)
In the next five years, respondents believe that use of biomarker data for patient identification will impact that dynamic, followed closely by the use of electronic health records, again for patient identification into a clinical trial. (appliedclinicaltrialsonline.com)
As more and more patients use their data to manage their own health, together with new payment models focused on wellness and outcomes that rely on clinical data, the breadth, depth and accuracy of healthcare will continue to improve. (appliedclinicaltrialsonline.com)
We executed a disciplined portfolio strategy to focus on human therapeutics, advanced our lead clinical stage CAR T programs, leveraged platform partnerships, and made data-informed decisions designed to maximize patient impact and extend our expected cash runway to the end of 2024," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. (biospace.com)
Thanks to the E-Diary, data about AHC spells in patients are recorded by trained caretakers in their Event Diaries on the IAHCRC-CLOUD Platform through the E-Diary App for mobile phones and PCs. (iahcrc.net)
Data from the patients' Event Diaries are then validated and automatically included in the OBSERV-AHC Study Database on the Platform, to be integrated with the patients' data collected by their clinicians and thus achieve the main OBSERV-AHC objectives about natural history and therapy for AHC. (iahcrc.net)
Some systems use 30-second single-lead ECG data to output an automated rhythm diagnosis (Kardiaband/Apple watch™, for example), but they were demonstrated to be able to interpret, and not always correctly, only approximately 2/3 of rhythm strips [ 11 ]. (hindawi.com)
That doesn't mean they are inherently unsafe, it just means that the safety profile is unclear for pregnant individuals, simply due to the lack of data. (acrpnet.org)
The EUAL procedure is intended to assist interested UN procurement agencies and Member States on the acceptability for use of a specific IVD in the context of a public health emergency, based on a minimum set of available quality, safety, and performance data. (who.int)

Using auditory stimulation such as music can facilitate walking but patients vary significantly in their response. (frontiersin.org)

Day 2 opened with three parallel sessions that explored the peer review process, the use of digital enhancements to maximise publication impact, and patient involvement in medical publications. (thepublicationplan.com)
4 In interviews, front-line staff involved in PCMH development often name patient involvement in advisory councils as one of the key factors to successfully implementing the PCMH model. (aafp.org)

A total of 88 adult patients are allocated in a ratio of 1:1. (biomedcentral.com)

The first is a National Heart, Lung, and Blood Institute-sponsored trial that is exploring the safety and efficacy of injecting stem cells into the heart muscle of Left Ventricular Assist Device recipients. (montefiore.org)
The poster presentation will highlight the first analysis of an allogeneic CD19 CAR T product composition to demonstrate that strategies intended to maximize stem central memory T-cell fraction (CCR7 + ) while limiting CD4 + CCR7 + differentiated fraction may improve safety and efficacy of CAR T therapy. (biospace.com)

In addition, other clinically relevant secondary endpoints, such as HiSCR90, improvements in International Hidradenitis Suppurativa Severity Score System (IHS) 4, abscess/nodule and draining tunnel counts as well as patient reported pain and quality of life outcomes also reached statistical significance at week 12. (pipelinereview.com)

4. A demonstrated sensitivity to grass or tree pollen known to induce SAR through a standard skin prick test. (astrazenecaclinicaltrials.com)

A combination of the ICIs nivolumab and ipilimumab was the first to evidence better progression-free and overall survival compared to sunitinib in patients with intermediate or unfavourable prognoses as evaluated by the International mRCC Database Consortium (IMDC). (bvsalud.org)

In this observational prospective study consecutive patients presenting for elective cardioversion (ECV) of AF, from November 2017 to November 2018, were enrolled. (hindawi.com)

If you're a patient, please refer your questions to your healthcare provider. (cdc.gov)
These experts bring related healthcare and patient safety expertise from their experience working in local hospitals, public health departments, professional associations, consumer groups, government, and global organizations. (cdc.gov)

Assessment measures will include CT scan, PET-scan and Patient Reported Outcome Measures (PROMs). (ifopa.org)
Burn patients should then undergo a burn-specific secondary survey, which should include a determination of the mechanism of injury, an evaluation for the presence or absence of inhalation injury and carbon monoxide intoxication, an examination for corneal burns, the consideration of the possibility of abuse, and a detailed assessment of the burn wound. (medscape.com)
This epidemic has demonstrated the need for a WHO emergency use assessment and listing procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency. (who.int)
iv) Vasectomized partner (provided that the partner is the sole heterosexual partner of the female patient of childbearing potential and that the vasectomized partner has received medical assessment of surgical success). (who.int)

3 Clinic leaders may need more effective strategies to promote patient engagement and patient-centeredness. (aafp.org)
Those rights, however, do not provide an effective incentive when patients are either small in number or poor. (who.int)
Conclusion: This Network Meta-analysis suggests that Baricitinib plus Remdesivir is more effective than the other anti-infective drugs in treating patients with COVID-19 in terms of clinical recovery at 14 days, mortality and adverse events outcomes. (bvsalud.org)
Designing effective drugs with a wide margin of safety and few side effects cannot always be achieved. (msdmanuals.com)

With studies of this kind and world-wide collaboration, we are able to give our patients access to the most innovative treatments that will transform the way we treat congenital heart disease in the future. (jdch.com)

Very little is known about differences in the immunologic response to vaccines or their protective efficacy, according to sex and age. (cdc.gov)
Does the pathway include evidence-based options to account for differences in patient characteristics and/or preferences? (ascopost.com)
An individualized approach adapting musical tempo to patients' gait cadence, and capitalizing on these individual differences, is likely to provide a rewarding experience, increasing motivation for walk-in PD. (frontiersin.org)

Venous insufficiency is a serious condition requiring active management participation, including lifestyle changes, medication, minimally invasive treatments, regular check-ups, and developing a strong support network. (whatscookingwithdoc.com)
Beliefs about generic medication safety and efficacy may be particularly relevant in the rural South, a geographic region characterized by high chronic disease prevalence and the highest stroke and coronary heart disease mortality in the United States (11,12). (cdc.gov)
However, because few patients can maintain euglycemia with lifestyle changes alone, most children and adolescents require medication. (medscape.com)

The prospective, single-arm study will enroll up to 250 patients at multiple sites globally . (jdch.com)
A prospective, single-arm, global multi-site clinical investigation study that will enroll a total of up to 250 patients. (jdch.com)
Once patients better understand the big picture they are more willing to enroll. (montefiore.org)

Planned duration of participation for each patient is at least 38 days, excluding the screening period. (rarediseases.org)
Patients used the application 78.8% (±28.2) of the prescribed duration and enjoyed it throughout the program. (frontiersin.org)
i) Female patients who refrain from heterosexual intercourse during the trial if the reliability of the heterosexual abstinence has been evaluated in relation to the duration of the clinical trial and is the preferred and usual lifestyle of the patient. (who.int)

Diseases1

Chemicals and Drugs2

Analytical, Diagnostic and Therapeutic Techniques and Equipment5

Psychiatry and Psychology7

Phenomena and Processes1

Disciplines and Occupations1

Anthropology, Education, Sociology and Social Phenomena1

Technology, Industry, Agriculture1

Information Science2

Named Groups1

Health Care17

Tolerability9

Trials22

Statistically significant5

Assess the efficacy1

Participants7

Clinically meaningful2

20234

Placebo-controlled2

Endpoint3

Therapeutic11

Preclinical1

Therapies5

Phase11

Pediatric2

Pharmacotherapy for patients1

Treatment42

Objective was to assess1

Methods1

Dose5

Meaningful1

Pregabalin4

Multicenter1

Optimal2

Results5

Clinical studies2

Effectiveness3

Symptomatic5

Performed in an outpatient1

Baseline2

Adherence1

Regulatory5

Improve health outcomes1

Monotherapy1

Significant3

Investigators1

Robust2

Signals1

Multidisciplinary3

Centers3

Interventions4

Methodology2

Primary8

Caregivers2

Type 2 diabet1

Initial2

Unmet need1

Minimal1

Pivotal1

Barriers2

Outcomes for patients1

Studies have demonstrated1

Data10

Significantly1

Involvement2

Adult patients1

Stem2

Improvements1

Sensitivity1

Survival1

20181

Healthcare2

Assessment4

Effective4

Access to the most innovative treatments1

Differences3

Medication3

Enroll3

Duration3