Clinical trials phase iii as topic. Medical search. Frequent questions

The trial is a pivotal Phase 2/3 clinical study evaluating teplizumab, an investigational compound under development for the treatment of individuals with recent-onset type 1 diabetes. (science20.com)
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). (bioworld.com)
Positive top-line data from two pivotal phase III studies of acne vulgaris treatment Twyneo from Sol-Gel Technologies Ltd. is doing the stock end-of the-year favors as shares closed up 19% at $17.50 on Tuesday. (bioworld.com)
Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. (mvm.com)
DRRX ) today announced that patient enrollment has been completed in PERSIST, the pivotal Phase 3 clinical trial of POSIMIR® (SABER®-Bupivacaine), an investigational locally acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. (prnewswire.com)

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection. (merck.com)
According a press release and a recent article from Drug Topics, AstraZeneca's investigational vaccine candidate AZD12222 expanded into a phase 3 clinical trial. (contemporaryobgyn.net)
Its implementation would allow clinical trial sponsors to circumvent the publication of whole documents (including trial protocols, subject information sheets, investigator brochures, the investigational medicinal product dossier, etc.) simply on the grounds that their economic interests might be potentially undermined (b,c). (prescrire.org)
The EMA also proposes to defer the trial information (e.g., trial protocols, investigational medicinal product dossier (IMPD) safety and efficacy sections) up to 10 years after the end of a trial by establishing a complex classification system that ranks clinical trial documents into different categories (as per the 'stage of development' of a medicinal substance or the 'intent' of a given trial). (prescrire.org)
POSIMIR is an investigational extended-release depot utilizing DURECT's patented SABER technology intended to continuously deliver bupivacaine to the surgical site for 72 hours, to provide up to three days of continuous pain relief after surgery. (prnewswire.com)
One late-stage product candidate in this category is POSIMIR ® (SABER ® -Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. (prnewswire.com)
Washington University School of Medicine in St. Louis is a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson's phase 3 clinical research study to evaluate the safety and efficacy of Janssen's investigational COVID-19 vaccine candidate. (wustl.edu)
Washington University School of Medicine in St. Louis is a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson's phase 3 clinical research study, called the ENSEMBLE trial, to evaluate the safety and efficacy of Janssen's investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. (wustl.edu)
The phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults 18 years old and older, including significant representation from those who are over 60. (wustl.edu)
A protocol describing the clinical study must be approved by an appropriate institutional review board (IRB) and the US Food and Drug Administration (FDA), which then issues an investigational new drug (IND) exemption permit. (msdmanuals.com)

As of September 2020, there were more than 3 million reported cases in the Americas [1] and the economic impact is considered to be significant. (mvm.com)

As reported in the Journal of Clinical Oncology by Goto et al, primary results of the phase II DESTINY-Lung02 trial have shown activity of fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-mutant metastatic non-small cell lung cancer (NSCLC) previously treated with platinum-containing. (ascopost.com)
In a 5-year analysis of the Japanese phase III JIPANG trial reported in the Journal of Clinical Oncology, Kenmotsu et al found no significant differences in overall or recurrence-free survival with adjuvant pemetrexed/cisplatin vs vinorelbine/cisplatin in patients with stage II-IIIA nonsquamous. (ascopost.com)
In the phase II HERTHENA-Lung01 trial reported in the Journal of Clinical Oncology, Helena Yu, MD, and colleagues found that patritumab deruxtecan (HER3-DXd), a new anti-HER3 antibody-drug conjugate, showed activity in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). (ascopost.com)
Journal of Clinical Oncology. (lu.se)

Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase 3 study called the PROTEGE Extension trial. (science20.com)
We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial. (science20.com)
In trials with a parallel study design a sizable number of patients seem to benefit from a placebo effect, although this effect is smaller in patients with systemic JIA. (nih.gov)
As monotherapy in second-line HCC, in addition to KEYNOTE-240 and KEYNOTE-224, KEYTRUDA is being investigated in the ongoing Phase 3, KEYNOTE-394 trial, a randomized, double-blind trial evaluating KEYTRUDA in combination with best supportive care, compared to placebo in combination with best supportive care, in Asian patients with advanced HCC who were previously treated with systemic therapy. (merck.com)
ClinicalTrials.gov, NCT02702401 ) evaluating KEYTRUDA plus best supportive care compared to placebo plus best supportive care in patients with advanced HCC who were previously treated with systemic therapy. (merck.com)
The study enrolled 413 patients who were randomized to receive either KEYTRUDA (200 mg fixed dose every three weeks for up to 35 cycles of treatment [up to approximately two years]) plus best supportive care (including pain management and management of other potential complications including ascites per local standards of care) or placebo plus best supportive care. (merck.com)
Initial results of a large clinical trial in patients with advanced prostate cancer show promise for a combination treatment approach using two existing medications: olaparib plus abiraterone . (pcf.org)
The PROpel trial includes patients with and without such gene changes. (pcf.org)
The trial will continue to follow patients to measure overall survival and other outcomes. (pcf.org)
I saw patient registries that had a laudable goal of attracting a broader population of patients, but those registries were still done at centers that participated in clinical trials. (medscape.com)
As we move from phase I to IV, this requires an increasing number of patients, and of course, cost. (hstalks.com)
The FDA advises that companies engaged in trials, specifically, the biopharmaceutical and medical device industries and their development organizations, should focus on what matters: risks to patients and risks to study data," Epstein says. (tableau.com)
Eli Lilly and Co.'s acquisition of Dermira Inc. for $1.1 billion in cash enlarges Lilly's dermatology pipeline with the addition of lebrikizumab, a monoclonal antibody designed to bind IL-13 with high affinity, now in two phase III studies for treating moderate to severe atopic dermatitis (AD) in adolescent and adult patients, ages 12 and older. (bioworld.com)
Before propensity-score matching, patients with a malnourished status demonstrated poorer clinical outcomes, including higher-in-hospital and 90-day mortality. (clinicaladvisor.com)
PERSIST is a Phase 3 clinical trial consisting of patients undergoing cholecystectomy (gallbladder removal) surgery. (prnewswire.com)
In a previous clinical trial of 50 patients undergoing laparoscopic cholecystectomy, POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. (prnewswire.com)
Researchers are assessing the safety and efficacy of fosgonimeton (ATH-1017) for the treatment of patients with mild to moderate Alzheimer disease in a phase 3 clinical trial. (psychiatryadvisor.com)
Researchers are conducting a phase 3 trial to evaluate the safety and efficacy of subcutaneously administered fosgonimeton by comparing high dose, low dose , and placebo treatment groups in patients with mild to moderate Alzheimer disease (AD). (psychiatryadvisor.com)
Patients are randomly assigned to these 3 treatment groups in a 1:1:1 ratio. (psychiatryadvisor.com)
If you attended the Annual Meeting of the American Society for Hematology (ASH) last December, then you might have noticed some exciting clinical-trial news about the treatment of multiple myeloma, especially for patients that have relapsed and/or are refractory to chemotherapies such as bortezomib. (cancertherapyadvisor.com)
Vorinostat, an oral histone deacetylase (HDAC) inhibitor manufactured by Merck that was previously approved by the Food and Drug Administration for the treatment of cutaneous T-cell lymphoma, has shown promising activity in patients with relapsed and/or refractory multiple myeloma and is currently in Phase 3 trials for this disease. (cancertherapyadvisor.com)
One oral presentation (Abstract No. 813) was titled "Final Results from the Bortezomib-Naive Group of PX-171-004, a Phase 2 Study of Single-Agent Carfilzomib in Patients with Relapsed and/or Refractory Multiple Myeloma. (cancertherapyadvisor.com)
CancerTherapyAdvisor.com is a free online resource that offers oncology healthcare professionals a comprehensive knowledge base of practical oncology information and clinical tools to assist in making the right decisions for their patients. (cancertherapyadvisor.com)
The biomarker-driven Lung Cancer Master Protocol (Lung-MAP) may have enrolled a higher percentage of patients who are older, are from rural or socioeconomically deprived areas, and have Medicaid or no insurance compared with conventional, standalone clinical trials in advanced non-small cell lung. (ascopost.com)
The oral KRAS G12C inhibitor adagrasib may offer durable clinical activity, with a median overall survival of 14.1 months and a 2-year survival rate of about 33%, in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), according to findings presented by Gadgeel et al at the. (ascopost.com)
Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab. (qxmd.com)
The number of sites of metastatic progression was 0 to 2 in 76% and 3 to 5 in 24% of the patients. (bvsalud.org)
In multivariable analysis, patients with 3 to 5 sites of metastatic progression had worse OS (HR 2.6, 95%CI 1.5-4.3, P (bvsalud.org)
Patients with 0 to 2 sites had better OS and longer TNT-D compared to those with 3 to 5 lesions. (bvsalud.org)
Archival tumour tissue from primary tumours and metastasis from patients included in clinical trials is characterised on protein and genomic level and the results linked to clinical outcome. (lu.se)
A large, randomized, double-blind trial [ 2 ] conducted in several countries studied benralizumab in patients (n=1306) with severe asthma poorly controlled with all conventional antiasthma treatments. (medscape.com)
In a subgroup analysis, [ 3 ] researchers looked at 83 patients randomly assigned in Japan, a country where abnormally high eosinophil levels associated with severe asthma naturally occur. (medscape.com)

The PIVOT-HD Phase 2 clinical trial is designed in two parts: an initial 12-week placebo-controlled phase focused on PTC518 pharmacology and pharmacodynamic effect, followed by a 9-month placebo-controlled phase focused on PTC518 biomarker effect. (acnr.co.uk)

The PROTEGE trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 weeks of their diagnosis. (science20.com)
The companies also announced today that they have initiated the PROTEGE ENCORE trial, another Phase 3 global study of teplizumab in individuals with recent-onset type 1 diabetes, designed to capture patient-reported outcome measures in addition to safety and efficacy data. (science20.com)
In trials with parallel study design and a 1-D outcome, the placebo effect was 0.35 (95% confidence interval [95% CI] 0.27-0.43). (nih.gov)
Participants already enrolled in the trials will continue to receive the study medicine. (merck.com)
The IMPOWER 22 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly compared to once-daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 Infection. (merck.com)
The Breast International Group (BIG) 1-98 study is a four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one followed by 3 years of the other for postmenopausal women with endocrine-responsive early invasive breast cancer. (nih.gov)
Prospective, Randomized, Blinded Phase 2 Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination with Optimized Background Regimen (OBR) for the treatment of MDR-TB. (cdc.gov)
Methods This non-randomized, multicohort, phase II study evaluated the efficacy and safety of the anti-PD-1 antibody nivolumab 240 mg administered every 2 weeks in combination with the CDK4/6 inhibitor abemaciclib 150 mg twice daily and either fulvestrant (FUL) or letrozole (LET) as a first-line or second-line treatment for HR-positive HER2-negative metastatic breast cancer. (bmj.com)
Rutgers University is a clinical trial site for the Janssen Pharmaceutical Companies of Johnson & Johnson's phase 3 clinical research study to evaluate the safety and efficacy of Janssen's COVID-19 vaccine candidate. (rutgers.edu)
In the PIVOT-HD trial, we aim to confirm the dose-dependent lowering of huntingtin protein that was demonstrated in our Phase 1 clinical study and gain insight to biomarker data that could provide meaningful evidence of treatment effect. (acnr.co.uk)
In a Phase 1 healthy volunteer study of PTC518 for Huntington's disease, PTC518 demonstrated a dose-dependent lowering of HTT mRNA and protein to the targeted 30-50% reduction. (acnr.co.uk)
There are tools out there that are good at providing bio-statisticians flexible insight into clinical data, but study management teams are often left to access data from several different systems and make sense of it on their own. (tableau.com)
All but 3 of 22 persons in the study who showed healing with the aloe cream had no recurrences 15 months after stopping treatment. (peacehealth.org)
This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy compared to psychotherapy with placebo in participants diagnosed with at least moderate PTSD. (clinicaltrials.gov)
This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy with placebo control in participants diagnosed with at least moderate PTSD. (clinicaltrials.gov)
The primary objective of this study is to evaluate the efficacy of MDMA-assisted psychotherapy for PTSD compared to identical psychotherapy with inactive placebo, as measured by change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Visit 3 (Baseline) to Visit 19 (18 weeks post Baseline) (Blake et al. (clinicaltrials.gov)
Genome-wide association study identifies three novel susceptibility loci for severe Acne vulgaris. (bmj.com)
A prerequisite for a successful study is the thorough planning of the clinical trial supplies. (gmp-navigator.com)
This study was conducted to evaluate whether there is congruence with numerical results of phase II trials and their overall verbal conclusions. (mcmaster.ca)
This is an open-label phase 1b study to determine the safety, tolerability, recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of selinexor in combination with R-CHOP in pts with NHL. (confex.com)
In addition, the document states that 'the EU database will not contain any individual patient listings from clinical trials' even though such listings are part of clinical study reports (f). (prescrire.org)
Rationale: We developed a standardized method, possible poor treatment response (PPTR), to help ascertain efficacy endpoints in Study S31/A5349 (NCT02410772), an open-label trial comparing two 4-month rifapentine-based regimens with a standard 6-month regimen for the treatment of pulmonary tuberculosis (TB). (cdc.gov)

Today we'll go over the objective of phase II trials, the clinical trial endpoints for the trials, as well as different phase II trial designs, including single-arm phase II trials, randomized phase II trials, phase II/III or phase I/II trials, as well as enrichment designs. (hstalks.com)
The most recent example is the positive top-line results from their collaborative phase III trial of baricitinib in treating adults with moderate to severe atopic dermatitis that show the oral selective JAK inhibitor met the study's primary and secondary endpoints. (bioworld.com)

PTC Therapeutics, Inc. announced on 31st March 2022 the initiation of the PIVOT-HD Phase 2 clinical trial evaluating PTC518 in people with Huntington's disease (HD). (acnr.co.uk)
Bone Therapeutics is gespecialiseerd in de ontwikkeling van celtherapieproducten bestemd voor de behandeling van osteoarticulaire ziektes en de regeneratie van botweefsel, op basis van een technologisch platform waarmee osteoblasten uit volwassen stamcellen geproduceerd kunnen worden. (belegger.nl)
Gosselies, Belgium, 3 March 2017, 7am CET - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it will release its full year results for the year ended 31 December 2016 on Thursday 16 March 2017. (belegger.nl)

This R61/R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. (nih.gov)
Animal experiments are useful in suggesting these connections, but many clinical trials including the Women's Health Initiative have shown that these findings are also true in humans. (researchgate.net)
Findings from the phase 3 INTERCEPT trial demonstrated that an orally administered, novel nonsteroidal anti-inflammatory drug (NSAID)/triptan medication is effective in treating migraine pain. (medscape.com)
The most notable changes in these guidelines reflect both the findings of clinical trials that evaluated new drug regimens for treating and preventing TB among HIV-infected persons and recent advances in the use of antiretroviral therapy. (cdc.gov)

This FOA will provide up to two years (R61 phase) of support for milestone-driven testing of bioavailability, pharmacokinetics, and assessment of the natural product's effect (i.e., measure of mechanism of action) when used by humans on a biological signature(s) . (nih.gov)
If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. (nih.gov)
Phase 1 evaluates safety and toxicity in humans. (msdmanuals.com)

Trending Clinical Topic: Migraine - Medscape - Jul 02, 2021. (medscape.com)

In a phase III clinical trial, we evaluate the superiority of a novel agent or regimen on patient outcomes, compared to the standard therapy. (hstalks.com)
Readouts from two ambitious pruritus trials this week yielded starkly different reactions from investors seeking broader meaning in the outcomes. (bioworld.com)
Low PNI scores were associated with poorer clinical outcomes in the subgroup analysis. (clinicaladvisor.com)
Secondary outcomes include evaluating patient cognition scores, Clinical Global Impression of Change scores, and Activities of Daily Living scores. (psychiatryadvisor.com)
Conclusions: Standardized methodologies, such as our PPTR approach, could facilitate unbiased efficacy outcome determinations, improve discrimination between outcomes that are related and unrelated to regimen efficacy, and enhance the ability to conduct pooled analyses of contemporary trials. (cdc.gov)

Two pharma companies have announced early COVID-19 vaccine trial results with over 90 per cent effectiveness. (theconversation.com)
It doesn't mean that the results of those trials are not accurate and valid, but it does raise real questions about their generalizability. (medscape.com)
Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. (nih.gov)
The FDA reviews the results of the clinical trial. (medlineplus.gov)
The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic. (techgenyz.com)
Based on the phase 2/3 trial results, SII with the help of ICMR will pursue the early availability of this product for India. (techgenyz.com)
CONCLUSIONS: There exist inconsistencies and ambiguities in the conclusions drawn from phase II trials, particularly when results are in the grey zone (greater than H0 but less than HA). (mcmaster.ca)
The safety profile is consistent with results from the Phase 1 clinical trial. (mvm.com)
Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva commented , "We are delighted with these Phase 3 results confirming the compelling profile of our vaccine candidate across all age groups. (mvm.com)
These first-ever Phase 3 trial results for a chikungunya vaccine mean that we are a step closer to addressing this major, growing and unmet public health threat. (mvm.com)
Final trial results are expected within the next six months. (mvm.com)
There can be no assurance that the PERSIST trial will show similar results, or provide sufficient data for FDA approval. (prnewswire.com)
In nonmedication treatment news, results of a randomized, sham-controlled trial found that a noninvasive, self-administered neurostimulation device recently approved by the US Food and Drug Administration is safe, tolerable, and offers "highly effective" pain relief in acute migraine. (medscape.com)
Onyx Pharmaceuticals announced Phase 2 trial results for Carfilzomib (PR-171) at ASH 2011. (cancertherapyadvisor.com)
With trial results now available, we know that this vaccine was not efficacious. (cdc.gov)
An external panel of experts convened by WHO analyzes the results from clinical trials, along with evidence on the disease, age groups affected, risk factors for disease, and other information. (who.int)

We continue to apply learnings from our HIV program as we move forward with the development of islatravir in both treatment and PrEP," said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. (merck.com)

Our mission is to provide practice-focused clinical and drug information that is reflective of current and emerging principles of care that will help to inform oncology decisions. (cancertherapyadvisor.com)
These NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) focus on peritoneal mesothelioma (PeM). (bvsalud.org)

Our research team will enroll a large number of volunteers into this extremely important vaccine trial. (rutgers.edu)
It's critical to have diverse participants in a coronavirus vaccine trial so we know it is effective for populations that are often underrepresented in research," said XinQi Dong , director of the Institute for Health, Health Care Policy and Aging Research and co-lead investigator who is directing community recruitment for the Johnson & Johnson trial. (rutgers.edu)
If you look at the titles, you'll start to see the same words coming up over and over again, and that gives us some really important clues of what people think are hot topics in research. (medscape.com)
Kathy D. Miller, MD, is associate director of clinical research and co-director of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University. (medscape.com)
Her career has combined both laboratory and clinical research in breast cancer. (medscape.com)
Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. (nih.gov)
however, medical researchers, institutions, and regulatory agencies are working to ensure that gene therapy research, clinical trials, and approved treatments are as safe as possible. (medlineplus.gov)
Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). (medlineplus.gov)
These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities. (medlineplus.gov)
Enjoyed this Research Topic? (frontiersin.org)
Instead, they recommend approaches that identify risks to patient safety by utilizing critical data elements gathered in clinical data systems as a method of determining which sites warrant additional attention from clinical research associates (CRAs). (tableau.com)
On Thursday, the Pune-based Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) announced the enrolment of phase-3 clinical trials for potential COVID-19 vaccine India's role in the production of COVID-19 vaccine critical in containing pandemic: Bill Gates Covishield in India. (techgenyz.com)
Most strikingly, neither the EU Clinical Trials Regulation nor the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects provide such a 'classification' (d). (prescrire.org)
Omnibus solicitations are structured to be broad, extensive Programmatic issuances with research areas related to the petitioning Agency and are not limited to predetermined Topics/Subtopics. (sbir.gov)
A safe and effective vaccine that can protect against COVID-19 infection is critical for ending the COVID-19 pandemic," said Rachel Presti, MD, PhD, an associate professor of medicine and medical director of Washington University's Infectious Diseases Clinical Research Unit , which is leading the trial. (wustl.edu)
The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and is designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19. (wustl.edu)
This leads to Phase-III of this research programme in which the most powerful targeted vectors will be chosen to be developed further, by inserting novel powerful therapeutic genes into them. (europa.eu)
Dive into the research topics where Lisa Ryden is active. (lu.se)
Received grants for clinical research from: Almirall Prodesfarma, S.A. (medscape.com)

The trial is funded by the Biomedical Advanced Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). (contemporaryobgyn.net)
To learn more about participating in the COVID-19 vaccine trial at Washington University School of Medicine, please email [email protected] or call 314-454-0058 or visit the Division of Infectious Diseases clinical trials website . (wustl.edu)

An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. (medlineplus.gov)
Ongoing anti-cancer gene therapy clinical trials have highlighted the need for more efficient and safer vectors. (europa.eu)

Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin in standard intensive phase TB treatment regimen. (cdc.gov)
1 Providing antimicrobial susceptibility testing of an isolate to aztreonam, ceftazidime-avibactam, 2 and aztreonam-avibactam 3 can provide useful information to guide patient treatment. (clsi.org)
Most clinical laboratories find it difficult to test some of the newer antimicrobial agents that might warrant consideration for treatment of highly resistant organisms. (clsi.org)
It can take years before these drugs are available on commercial antimicrobial susceptibility testing systems used in clinical laboratories. (clsi.org)

Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. (medlineplus.gov)
Our groups is multidisciplinary including clinical PhD students and clinical researchers along with a biostatistician, molecular biologist and technical personnel. (lu.se)

The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. (medlineplus.gov)
The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened. (bioworld.com)
Participants will be randomized to receive a flexible dose of 80 or 120 mg MDMA or placebo, followed by a supplemental half-dose of 40 or 60 mg MDMA or placebo, unless contraindicated, with manualized psychotherapy in three monthly Experimental Sessions. (clinicaltrials.gov)
Each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy to help the participants process and understand their experiences during the Experimental Sessions. (clinicaltrials.gov)
The trial, involving 4,115 adults, aged 18 years and above, across 44 sites in the U.S., met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95%CI: 96.2-99.6). (mvm.com)
The Phase 3 trial compares several outcome measures and the safety profile of vorinostat alone or in combination with bortezomib in 637 participants with progressive multiple myeloma and was presented by Merck as Abstract No. 811 at ASH. (cancertherapyadvisor.com)

We'll go over the objective of phase II trials. (hstalks.com)
The phase II trial objective, which is the topic of today, is a signal of drug activity, worthy of moving forward to phase III. (hstalks.com)
OBJECTIVE: There appears to be considerable confusion about the interpretation of phase II clinical trial conclusions as contrasted with the alternative (HA) and null (H0) hypotheses. (mcmaster.ca)

The hope is that real-world data and increasingly sophisticated big data tools allow us to evaluate real-world data that will supplement and complement what we can learn from randomized clinical trials. (medscape.com)
Blood samples were obtained on days 0, 3, 5, 8 and 15 for RNA isolation followed by RT-PCR to evaluate the expression of targets or downstream effectors including XPO1, AABCG2, AKT, Bcl-2, Bax and ERK. (confex.com)
This made it possible to develop COVID-19 vaccines and fully evaluate them in clinical trials much faster than before. (who.int)

The enhanced design f the trial enabled two complementary analyses of efficacy and safety. (nih.gov)
Once a clinical trial indicates that a COVID-19 vaccine is safe and effective, a series of independent reviews of the efficacy and safety evidence is required. (who.int)

Since 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) is applicable. (gmp-navigator.com)

The European Medicines Agency (EMA) must stay true to the Clinical Trials Regulation: non-disclosure has to remain the exception, not become the norm! (prescrire.org)
The European Medicines Agency's (EMA) proposal regarding the specifications of the European Union (EU) clinical trials database can jeopardise the transparency advances obtained through the European Clinical Trials Regulation. (prescrire.org)
On 2 April, 2014, the adoption of the new EU Clinical Trials Regulation showed a strong political commitment to transparency by both the European Parliament and Council (1). (prescrire.org)
The EMA's draft proposal aims to interpret the transparency exceptions established in the European Clinical Trials Regulation (Regulation (EU) No 536/2014) (2). (prescrire.org)
Juan Erviti, Secretary of the International Society of Drug Bulletins (ISDB) highlights: 'The EMA's draft is at odds with the principle enshrined in the Clinical Trials Regulation, which is to increase public access to valuable information on clinical trials. (prescrire.org)
On the contrary, the EU Clinical Trials Regulation clearly highlights the importance of providing public information, even requiring Member States to establish penalties in cases of non-compliance. (prescrire.org)

The majority of solicited adverse events were mild or moderate and resolved within 3 days. (mvm.com)
Phase 4 typically involves larger populations and longer time periods than phases 1 to 3, which helps detect uncommon or slowly developing adverse effects that are unlikely to be recognized in shorter, smaller studies. (msdmanuals.com)
Some drugs approved by the FDA after phase 3 have been withdrawn from the market after newly recognized and serious adverse effects have occurred in phase 4. (msdmanuals.com)

Randomized, placebo-controlled, double-blind Phase I/II clinical trial assessing the safety and microbiological activity of Linezolid added to Optimized Background Therapy (OBT) for MDR TB or XDR TB. (cdc.gov)
Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for isoniazid in standard intensive phase TB treatment regimen. (cdc.gov)
Older case studies reported that aloe gel applied topically could help heal radiation burns, but a large, double-blind trial did not find aloe effective in this regard. (peacehealth.org)
A gel containing the polysaccharide acemannan was found in one double-blind trial to speed the healing of canker sores better than the conventional treatment Orabase Plain. (peacehealth.org)
A double-blind trial using a 0.5% Aloe vera cream found that applying the cream three times a day shortened the healing time of genital herpes outbreaks. (peacehealth.org)
A double-blind trial in Pakistan found that topical application of an extract (0.5%) in a cream was more effective than placebo in the treatment of adults with psoriasis. (peacehealth.org)
In a double-blind trial, people with seborrheic dermatitis applied either a 30% crude aloe emulsion or a similar placebo cream twice a day for four to six weeks. (peacehealth.org)

Biometrics 73, no. 3 (2017): 1042-1052. (unc.edu)

The traditional paradigm of drug development moves from phase I, where a new drug is evaluated for the appropriate dose, scheduling of delivery, as well as toxicity, and at the end of the phase I trial, we arrive at the recommended phase II dose, which is sometimes also called the maximum tolerated dose. (hstalks.com)

Comments on Medscape are moderated and should be professional in tone and on topic. (medscape.com)

Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. (cdc.gov)

A standard 3 + 3 dose escalation design in which pts received 6 cycles of R-CHOP (rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 IV, vincristine 0.5 mg/kg on day 1, prednisone 100 mg po on days 1-5 in a 21 day cycle) and 60 mg or 80 mg selinexor on days 1, 8, and 15 of each cycle was used. (confex.com)

Studies presented at the recent American Headache Society (AHS) Annual Meeting resulted in this week's top trending clinical topic. (medscape.com)
Given the often debilitating symptoms associated with migraine, it is no wonder that so many presentations at AHS focused on the condition or that it became this week's top trending clinical topic. (medscape.com)

The vaccine candidate was highly immunogenic with a GMT of approximately 3,270, confirming the immunogenicity profile seen in the Phase 1 trial. (mvm.com)

METHODS: A literature search of 2006 and 2007 phase II clinical trials was conducted. (mcmaster.ca)
Articles by Country Search - Search articles by the topic country. (cdc.gov)
Enter search terms to find related medical topics, multimedia and more. (msdmanuals.com)

This phase also compares the drug with existing treatments, a placebo, or both. (msdmanuals.com)

The prediction models integrate patient´s, clinical and tumour related data to achieve high accuracy. (lu.se)

For aztreonam-avibactam, a minimum inhibitory concentration (MIC) is reported without an interpretation because clinical breakpoints for this drug combination have not been established. (clsi.org)
The number of drugs that are successful through each phase of drug development decreases. (hstalks.com)
CLINTEL (formerly Advanced Bio-Logic Solutions) identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles. (tableau.com)
During the Treatment Period, each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy. (clinicaltrials.gov)
RELIEF, a randomized controlled trial , showed that those who received the drug were more likely to be free of pain (9.7%) and their most bothersome symptom (33.2%) at 1 hour, compared with those who received placebo (4.1% and 22.1%, respectively). (medscape.com)
Benralizumab was approved by the US Food and Drug Administration (FDA) after several phase 3 trials. (medscape.com)
However, the first approval of a "biologic" for asthma is nonetheless a landmark, and the drug has clearly established efficacy in a clinical trial over relatively short periods. (medscape.com)

Adenovirus Vaccine Efficacy Trial Consortium (2013). (wikipedia.org)

We have been pleased with MacroGenics' conduct of the PROTEGE trial, and we are enthusiastic about the teplizumab clinical development program and expanding our efforts in the area of type 1 diabetes. (science20.com)
The ICMR and SII have collaborated for the clinical development of Covovax developed by Novavax, US and upscaled by SII, a statement said. (techgenyz.com)
This may make the integration of phase II trials in phase III trial development strategies difficult and better understanding of the statistical properties of phase II clinical trials is required. (mcmaster.ca)
DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. (prnewswire.com)
This proposal brings together European leaders with expertise covering from the development of novel viral vectors to the implementation of clinical trials of gene therapy. (europa.eu)
The editors were careful to include chapters on important nonscientific aspects of HIV vaccine development, such as clinical site development, regulatory issues, scale-up, and manufacturing. (cdc.gov)

At the recommendation of the ISL PrEP external data monitoring committee (eDMC), Merck is pausing enrollment for the IMPOWER 22 and IMPOWER 24 trials while the company conducts further analyses of these and other ongoing studies. (merck.com)
Since clinical trials are designed to collect important data about a potential drug's safety and efficacy, there's no shortage of data that can also be used to assess risk. (tableau.com)
The CLINTEL team, with its decade of experience offering electronic data collection system services for companies engaged in the clinical trials process, knew that an effort to enable this sort of analysis to clinically-focused users would face some distinct challenges. (tableau.com)
3 Stars Reliable and relatively consistent scientific data showing a substantial health benefit. (peacehealth.org)
Data were collected from the Medical InformationMart for Intensive Care III (MIMIC-III) database. (clinicaladvisor.com)
The trial will continue towards final analysis including the 6-month safety data. (mvm.com)
In fact, public access to clinical trial data allows independent analysis, enhancing knowledge about the real benefits and harms of medicines (a). (prescrire.org)
Transparency of clinical trial data should always be the default position. (prescrire.org)
According to Pierre Chirac, coordinator of the Medicines in Europe Forum (MiEF): 'Clinical trial sponsors will feel entitled to postpone or even avoid the publication of clinical data on the grounds of commercial confidentiality or 'trade secrets' protection. (prescrire.org)
Moreover, by proposing to defer the publication of information, such as protocols, up to 10 years after the end of a trial, the EMA demonstrates that it regards clinical trials as industry data, not as scientific data of public interest' (e). (prescrire.org)
Pattern mixture models for clinical validation of biomarkers in the presence of missing data. (unc.edu)
We thus aim to obtain well characterized, safe, and efficient gene therapy vectors, as well as pre-clinical data supporting the further testing of such vectors in clinical trials. (europa.eu)

Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active cases, using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month daily therapy with isoniazid. (cdc.gov)
This FOA will not support efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. (nih.gov)
Phase I studies determine if a treatment is safe for people and identify its side effects. (medlineplus.gov)
Phase II studies determine if the treatment is effective, meaning whether it works. (medlineplus.gov)
Phase III studies compare the new treatment to the current treatments available. (medlineplus.gov)
This ~12-week Treatment Period will be preceded by three Preparatory Sessions with the participant and therapists. (clinicaltrials.gov)
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a potential treatment option for PTSD. (clinicaltrials.gov)
A flexible dose of MDMA or placebo, followed by a supplemental half-dose unless contraindicated, will be administered during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. (clinicaltrials.gov)

Among the first 3 pts in the 60 mg cohort, there was an episode of grade 3 supraventricular tachycardia and an episode of grade 3 syncope. (confex.com)

Comparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer. (unc.edu)
Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. (qxmd.com)
In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that were higher than those with placebo in a phase 3 trial. (qxmd.com)

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. (merck.com)
The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at a RAC public meeting. (medlineplus.gov)
These trials, which include some groups at high risk for COVID-19, were specifically designed to identify any common side effects or other safety concerns. (who.int)

The clinical trial process occurs in three phases. (medlineplus.gov)

He is a pediatrician from the University of Tennessee, College of Medicine, and later on he will be talking to us about medical monitoring and give a presentation about how we establish guidelines for clinical practice. (cdc.gov)

The common heart disorder affects more than 3 million Americans. (drugwatch.com)
Phase 2 determines whether the compound is active against the target disorder. (msdmanuals.com)

Current Topics in Microbiology and Immunology. (wikipedia.org)

These guidelines update previous CDC recommendations for treating and preventing active tuberculosis (TB) among adults and children coinfected with human immunodeficiency virus (HIV) (1-3). (cdc.gov)
Eastern, where the topic will be clinical management of critically ill adults with COVID-19. (cdc.gov)

DURECT remains responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions through approval. (prnewswire.com)

MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the PROTEGE trial achieved its targeted patient enrollment. (science20.com)

While trials have indicated that several COVID-19 vaccines to have high levels of efficacy, like all other vaccines, COVID-19 vaccines are not 100% effective against the disease. (who.int)

Comedogenesis: some new aetiological, clinical, and therapeutic strategies. (bmj.com)

This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. (nih.gov)

In August 2013, the FDA finalized guidance on the topic of a "risk-based approach" to monitoring clinical trials. (tableau.com)

I would like to thank everyone who participated in the trial and who continued to advance the trial during the pandemic. (mvm.com)
Because the clinical trials took place in the middle of the pandemic with many people getting exposed, it was easier for clinical trials to see if the vaccines worked or not. (who.int)

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