Articles tagged with Clinical Trials
A Phase 3 study led by Massachusetts General Hospital found cytisinicline to be effective in reducing nicotine dependence and cravings, with impressive results. The medication was also well-tolerated, with no serious side effects reported, offering a new potential treatment option for smoking cessation.
A randomized clinical trial found that treatment with these biologics showed no significant difference in time to recovery compared to placebo for patients hospitalized with COVID-19 pneumonia. The study's results suggest that alternative treatments may be needed for this patient population.
Research leaders collaborate with organizations and regulators to develop digital tools for Parkinson's clinical trials. The Digital Drug Development Tools initiative accelerates the regulatory endorsement of these tools, enabling more objective and patient-centered measures.
A clinical trial of a three-month tuberculosis treatment regimen has been closed due to high rates of unfavorable outcomes. Participants who received the investigational treatment experienced ongoing or recurring TB at rates above thresholds set in the study protocol.
A new study published in NEJM Evidence validates a predictive AI biomarker for androgen deprivation therapy (ADT) benefit in prostate cancer. The study found that personalized use of short-term ADT could improve patient outcomes in men with predominantly intermediate-risk prostate cancer.
A new mRNA vaccine, SYS6006, was evaluated for its safety and immunogenicity as a fourth-dose booster in healthy Chinese adults. The study found that the vaccine elicited higher titers of antibodies against Omicron variants compared to convalescent patients.
A clinical trial has shown that desmopressin may reduce the risk of death or disability in stroke patients taking antiplatelet drugs. The results support the need for a large-scale trial to determine its effectiveness.
A world-first trial by the University of Sydney found that opioids do not alleviate acute back and neck pain, but may cause harm. The researchers recommend updating treatment guidelines to advise against opioid use for this purpose.
The AACR journal article explores steps to improve diversity in clinical trials, following a new law requiring trial sponsors to submit Diversity Action Plans to the FDA. Experts discuss key areas for consideration, including dedicating funding and staff, embedding DEI strategy, and engaging with community organizations.
Researchers at UC San Diego found a novel combination of KRAS and ERBB drug inhibitors outperformed treatments in human and mouse models of pancreatic cancer. The combination reduced drug resistance and increased survival rates.
A new drug, mirikizumab, has demonstrated a doubling in remission rates for ulcerative colitis patients, with up to 50% achieving clinical remission. The treatment showed little to no side effects and was found to be safe, offering a promising option for those with moderately severe and severe forms of the disease.
A small study suggests that vaginal progesterone treatment can increase the chances of conception in couples with unexplained infertility. The treatment, which is safe and low-cost, showed more than double the birth rate among treated women, but further research is needed to confirm these results.
A new study finds that exposure to posthospitalization home-delivered meals is associated with lower 30-day rehospitalization and mortality rates. The study suggests that this service may help prevent hospital readmissions and improve patient outcomes.
Cartesian Therapeutics has successfully treated patients with generalized myasthenia gravis using an RNA CAR-T therapy. The trial demonstrated marked and long-lasting clinical improvement, with three patients achieving complete or near-complete eradication of disease symptoms.
A small-scale clinical trial suggests a modified CAR-T therapy could effectively reduce myasthenia gravis symptoms, with three patients showing complete elimination of symptoms. The treatment was well-tolerated and has the potential for longer-lasting results compared to current treatments.
COPD patients treated with dupilumab experienced rapid and sustained improvements in disease, as measured by reduced acute exacerbations, better lung function, and improved quality of life. This is the first biologic to show clinical outcomes improvement in COPD.
A new patient-guided intervention using telemedicine has been shown to improve symptoms of fatigue, pain, and depression in dialysis patients. The Technology Assisted Stepped Collaborative Care (TĀCcare) trial found significant improvements in energy levels and pain severity that persisted for six months after treatment.
A clinical trial found that benralizumab effectively depleted eosinophils, but it did not alleviate symptoms or improve gut tissue health in patients with eosinophilic gastritis. The study's findings suggest a new therapeutic target for eosinophilic gastrointestinal diseases and highlight the need to reconsider remission definitions.
The study found no improvement in freedom from progression rates for patients receiving combined EBRT and brachytherapy (COMBO) compared to those receiving brachytherapy alone (BT). Late adverse events were significantly increased in the COMBO arm, favoring BT as a standard of care for intermediate-risk prostate cancer patients.
The FRESCO-2 trial shows that fruquintinib significantly improved overall survival and progression-free survival in patients with refractory metastatic colorectal cancer. The median OS was 7.4 months with fruquintinib versus 4.8 months in the placebo arm.
The TCT 2023 Program Guide features four days of innovation and cutting-edge science in interventional cardiovascular medicine. The event marks 35 years of leading the field and will gather top researchers and clinicians to present evidence-based research.
Researchers at UCL have developed base-edited T-cells that can fight leukemia, showing promise in a NHS clinical trial. Three patients with relapsed T-cell leukaemia were treated with the cells, with one patient experiencing complete remission after just four weeks.
The Better Together trial partners with community organizations and sites to provide buprenorphine treatment, reducing distance for patients and offering peer support in familiar environments. Researchers aim to address barriers such as stigma, misunderstandings about addiction, and bias against certain treatments.
Researchers have made progress in generating stem cell-derived beta cells, but current methods are costly and labor-intense. A recent study has found a simple method to address these issues, enhancing maturation and functionality of sBCs.
A statewide pay-for-performance intervention based on Choosing Wisely reduced rates of inappropriate antibiotic prescriptions for acute respiratory tract infections from 43% to 25%. This reduction occurred without measurable harms at safety-net hospitals serving disadvantaged patients.
A chatbot-based system improved the informed consent process for genomics research studies, leading to faster completion, higher understanding, and increased accessibility. The study involved 72 families and found that 96% of participants passed a quiz assessing their knowledge, with 86% reporting a positive experience.
A powerful new stem cell technique has enabled large-scale studies of the relationship between human genetics and biology, accelerating research and potential personalized treatments.
The African-led PrEPVacc trial has completed participant enrolment at all four sites in East and Southern Africa. The trial is testing two different ways to prevent HIV, including HIV vaccine regimens and a new form of oral pre-exposure prophylaxis (PrEP).
Researchers have made a breakthrough in treating melanoma by adding an mRNA vaccine tailored to individual tumour genetics to common immunotherapy, significantly improving survival and disease recurrence rates. After two years, cancer-free survival increased to 78.6%, and the risk of death or cancer returning was reduced by 44%.
The BCG vaccine, primarily developed to prevent tuberculosis, was found ineffective against COVID-19 in a large international trial involving nearly 4,000 healthcare workers. Researchers discovered that vaccination increased the risk of symptomatic disease during the first six months following enrolment.
A recent commentary highlights a potential hidden source of bias in electronic health records, which can impact clinical trials. Embedded pragmatic clinical trials rely heavily on EHRs for data collection, excluding people from underrepresented groups due to lack of access or inaccurate data collection.
A recent study published in The Journal of Orthopaedics found that patients who underwent partial meniscectomy using a needle arthroscopic technique experienced significantly less pain and improved patient-reported outcomes at two weeks after surgery. However, differences were not sustained at six weeks.
A randomized clinical trial found that peer health coaching improved mental health-related quality of life in veterans with cardiovascular disease risks. The study suggests a peer-support model integrated into primary care can lead to well-being improvements beyond blood pressure control.
Researchers analyzed data from 120 clinical trials and found no evidence that treatment efficacies differ depending on the number of comorbidities. The study suggests that modest levels of comorbidities do not affect treatment outcomes, providing valuable insights for clinicians to make informed recommendations.
A supervised hospital walking program has been shown to reduce nursing facility admissions for older adults by lowering the proportion of patients discharged to skilled nursing facilities from 13% to 8%. However, low participation rates and limited impact on length of stay or inpatient falls were noted.
Researchers at Sanford Burnham Prebys have discovered a new treatment for autoimmune diseases using LY3361237, an antibody that activates BTLA to inhibit the immune system. The study provides insight into the molecular biology of the immune system and could lead to the development of more effective therapies.
Erdafitinib achieves tumor-agnostic benefits across 16 cancer types, including urothelial, lung, and other cancers. The trial demonstrated a disease control rate of 73.7% and clinical benefit rate of 45.6%, with notable improvements in pancreatic and cholangiocarcinoma patients.
The Phase 3 S1826 trial demonstrates one-year progression-free survival in 94% of patients with Stage 3 or 4 classic Hodgkin lymphoma treated with nivolumab and chemotherapy. The therapy was well-tolerated, with few serious immune-related side effects.
A phase 3 clinical trial by Dana-Farber Cancer Institute has shown vorasidenib significantly prolongs progression-free survival and delays radiation and chemotherapy for patients with Grade 2 IDH-mutant glioma. Treatment with vorasidenib can delay cognitive dysfunction in patients and preserve their quality of life.
A new targeted therapy drug vorasidenib has been shown to extend treatment time without worsening glioma in people with IDH1 and IDH2 mutations. The study suggests a possible new treatment option for slow-growing but deadly brain tumors, delaying chemotherapy and radiation.
Analysis of rare cancer patients treated with checkpoint inhibitors reveals a linear correlation between tumor shrinkage and patient survival, contradicting earlier threshold-based models. The study suggests that using partial- or complete-response rates may miss signals of longer survival.
A study found that adding ribociclib to hormone therapy significantly improves invasive disease-free survival rates in patients with stage 2 or 3 HR positive/HER2 negative breast cancer. The combination therapy reduced the risk of cancer recurrence by 25%, with a three-year invasive disease-free survival rate of 90.4%.
A Phase II trial led by MD Anderson Cancer Center showed that zanidatamab achieved a 41% confirmed objective response rate and durable responses in HER2-positive biliary tract cancer. This represents the largest study of a HER2-targeted drug in BTC, providing evidence for its potential as a new treatment option.
A phase II trial showed that patients with extensive stage SCLC expressing the Schlafen-11 gene had significantly longer progression-free survival when treated with atezolizumab and talazoparib. The study demonstrates improved outcomes for patients with SLFN11-positive SCLC, paving the way for personalized therapy approaches.
A phase 2 trial found that immune checkpoint inhibitor pembrolizumab had a durable antitumor effect in 24 of 57 patients with metastatic brain cancer. The study achieved its primary endpoint, with median overall survival of 8 months and seven patients surviving longer than two years.
A randomized clinical trial suggests that low-dose atropine may provide a treatment option for childhood myopia progression. The study observed a significant reduction in myopia progression over 3 years.
In a multicenter trial, pirtobrutinib demonstrated reversible and effective inhibition of defective B-cells in patients with poor survival prognosis. Over half of patients responded to the drug, with a median duration of response of 21.6 months.
A new clinical trial found that low-dose atropine eye drops are effective in slowing the progression of nearsightedness in children. The treatment showed significant improvements in limiting eyeglass prescription changes and inhibiting elongation of the eye, with a daily drop in each eye being enough to make a difference.
The SISAQOL-IMI Consortium establishes an international consensus on patient-reported outcomes in cancer trials, aiming to improve the use of PROs. The new standards will enhance patient involvement and ensure the relevance of recommendations to the patient community.
Decentralized trials aim to improve access to clinical research, but disparities in technology access and potential barriers to trust remain unknown. Rigorous randomized controlled trials are needed to evaluate the impact of decentralized trials on trial enrollment and pipeline aspects.
Researchers found that a reduction in body weight of 1% led to participants' brain age being almost 9 months younger than expected. This attenuation of brain aging was associated with changes in liver fat and enzymes, which can negatively affect brain health in Alzheimer's disease.
Researchers found that ropinirole is safe and effective in slowing ALS progression, with patients showing improved physical activity and muscle strength after treatment. The study suggests that the method of growing motor neurons from patient-derived stem cells could be used to predict a patient's response to the drug.
A large study tracked CIPN in over 1,100 breast cancer patients treated with taxanes, showing persistent sensory and motor symptoms with more severe symptoms with paclitaxel than docetaxel. The study defines a risk prediction model to help doctors individualize patient care.
A recent study has demonstrated the safety and effectiveness of a liver dialysis device in treating acute-on-chronic liver failure (ACLF). The device, DIALIVE, was associated with significant improvements in symptoms and organ function compared to standard care.
The SWOG Cancer Research Network will present 30 abstracts at the ASCO 2023 annual meeting, highlighting primary results from trials S1011, S1826, S1714, and S1929. Additionally, analysis from the S1609 DART trial will be shared publicly during the meeting.
Researchers presented findings on pembrolizumab for brain metastases, virtual mind-body interventions for post-treatment survival, and dynamic HER2-low status in triple negative breast cancer. The studies aim to improve treatments and outcomes for patients with cancer.
A clinical trial using DIALIVE, a novel liver dialysis device, demonstrated significant improvements in all main underlying pathophysiological mechanisms of acute-on-chronic liver failure. Treatment resulted in accelerated resolution of ACLF and sustained improvement in biomarkers.
Two Kessler Foundation scientists will conduct studies on upper extremity exercise after stroke and restoration of cardiovascular function in spinal cord injury populations. Dr. Shenoy Handiru's study combines transcranial electrical stimulation and wearable sensor-based exergaming to improve hand dexterity, while Dr. Einat Engel-Haber...
A phase 3 trial found that extending lymphadenectomy beyond the standard procedure does not reduce disease recurrence or improve survival in patients with locally advanced bladder cancer. Instead, it increases the risk of adverse events and post-surgical death.
Dana-Farber researchers present promising results for patients with rectal, brain, and kidney cancers in phase 3 trials. The PROSPECT trial shows neoadjuvant chemoradiation versus FOLFOX chemotherapy offers improved survival benefits for locally advanced rectal cancer patients. Additionally, the INDIGO trial demonstrates vorasidenib's ...