Phase ii clinical therapeutic trials clinical trials phase ii as topic. Medical search. Frequent questions

This article covers current concepts and recent advances in TB drug discovery and development, including an update of ongoing TB treatment trials, newer clinical trial designs, TB biomarkers and adjunct host-directed therapies. (nih.gov)
Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials, phase 2-3 trials if warranted by the nature of the studied population (such as rare diseases), and platform trials where applicable. (nih.gov)
The NINDS Biomarkers Program supports rigorous clinical and analytical validation existing candidate biomarker measures or endpoints in a manner that is consistent with the purpose of the biomarker, and FDA guidelines. (nih.gov)
The goal of this program is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond). (nih.gov)
BNZ-1 showed activity in all doses as it was determined by early signs of clinical efficacy and PD biomarkers. (confex.com)
The researchers then built a model using the biomarkers as well as age and sex, two established risk factors. (bio-itworld.com)

Reports of efficacy outcomes were limited to randomized, controlled trials. (nih.gov)
GALILEO-1 is a first-in-human, international, multicenter Phase 1/2 dose-finding study assessing the safety, tolerability, and efficacy of a single intravenous dose of FLT201, the company's adeno-associated virus (AAV) gene therapy candidate for Gaucher disease Type 1. (freeline.life)
The trial is continuing into the Phase-2 dose expansion to establish definitive efficacy with an intent for registration. (cholangiocarcinoma.org)
Viking plans to begin dosing hip fracture patients in a Phase 2 efficacy trial of VK5211 in the fourth quarter of 2015. (prnewswire.com)
Viking is proceeding with plans to initiate its previously-announced randomized, double-blind, parallel group, placebo-controlled Phase 2 study to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. (prnewswire.com)
A multicenter, open-label Phase 1/2 study was completed to characterize the safety and efficacy of BNZ-1 (NCT03239392). (confex.com)
Subsequently, we selected the 2 mg/kg based on PK/PD relationship and clinical efficacy and expanded to a total of 19 patients. (confex.com)
Clinical efficacy was measured by mSWAT and Global Response Score (GRS) as defined previously (Olsen E. et al. (confex.com)
2 In this text, the principles for testing the efficacy of a new medication were laid out, including that the drug must be free from any extraneous accidental quality and that the experimentation must be performed with the human body. (cancertherapyadvisor.com)
A lackluster efficacy signal has prompted Editas Medicine Inc. to pause enrollment in a phase I/II trial of its CRISPR/Cas9-based gene editing therapy, EDIT-101, which is in development for patients with a particular form of Leber congenital amaurosis type 10. (bioworld.com)
To grant a treatment indication to a pharmaceutical agent, the U.S. Food and Drug Administration (FDA) requires pivotal clinical trials to show efficacy on disease-specific endpoints. (medpagetoday.com)
The later phases of the study tend to get larger as the researchers establish safety and efficacy. (healthtrustpg.com)
In early-stage Phase I/II trials in liver, pancreatic and colorectal cancers, YIV-906 has demonstrated safety and promising efficacy, with the potential to improve survival and quality of life for patients. (nfcr.org)
Scientists at the International Agency for Research on Cancer (IARC) have completed a study to assess the efficacy and safety of the use of therapeutic human papillomavirus (HPV) vaccines in phase II/III trials to treat women with moderate to advanced cervical lesions, and to achieve clearance of high-risk HPV from the cervix. (who.int)
The study concluded that the vaccines had a modest efficacy in treating grade 2 or 3 lesions (CIN 2/3), and that the observed high HPV clearance rates should be studied further to determine whether therapeutic HPV vaccination may lead to a more rapid and durable elimination of the virus in HPV-positive women with no precancerous or cancerous lesions. (who.int)
Given its reported efficacy in both types of hemophilia without inhibitors, concizumab is evolving as an attractive therapeutic for all patients with hemophilia. (cdc.gov)
We conducted the explorer7 trial to assess the safety and efficacy of concizumab in patients with hemophilia A or B with inhibitors. (cdc.gov)
However, because no data exist regarding the efficacy of this therapy for persons with nonoccupational HIV exposure, it should be considered an unproven clinical intervention. (cdc.gov)

Initial clinical data, with a focus on assessments of safety and enzyme activity, from the first cohort of the GALILEO-1 Phase 1/2 trial of FLT201 is expected in the third quarter of 2023. (freeline.life)
Cite this: Ecopipam Reduces Tourette's Tics Without Common Side Effects in Phase 2 Trial - Medscape - Jan 18, 2023. (medscape.com)
Novartis also plans to share the long-term results from the trials in 2023. (novartis.com)

June 5, 2020 More updates on SARS-CoV-2 research and COVID-19 from the Bio-IT Community including an app to create COVID-19 severity scores, new insights into viral behavior, modeling tools for the virus structure, and an influx of funding from Illumina, the Department of Defense, AstraZeneca, and more. (bio-itworld.com)
July 27, 2020 -- Moderna has begun a phase III clinical trial evaluating its messenger RNA (mRNA)-1273 COVID-19 vaccine candidate. (scienceboard.net)

The elimination half-lives of investigational orexin receptor antagonists are 2 to 3 hours for seltorexant and about 1.5 to 3 hours for vornorexant. (wikipedia.org)
Two potential candidate compounds, NCX 434 and NCX 422, have been selected and Nicox expects to commence pre-Investigational New Drug (IND) development activities with at least one of these candidates. (nicox.com)
Final stages of translation for FDA investigational device exemption (IDE) and early-stage clinical trials might be a candidate for one of the NINDS cooperative agreement programs. (nih.gov)
Refractory patients, who have failed FDA-approved or investigational treatments appropriate for the stage of their disease, with a diagnosis of mycosis fungoides (MF) of any stage or Sézary syndrome (SS) were eligible for this trial. (confex.com)
Investigational study: Also known as clinical trials, these studies test an assigned intervention on people. (healthtrustpg.com)
Moderna is leading the trial and is providing its investigational vaccine. (scienceboard.net)
This is an exciting potential new treatment for patients afflicted with nonsense-mutation-mediated CF. We look forward to the next stage of clinical development to demonstrate the benefits of this promising new investigational drug. (cff.org)
PTC124 is an orally delivered investigational new drug in Phase 2 clinical development for the treatment of genetic disorders due to nonsense mutations. (cff.org)

The vaccine was jointly developed by Moderna and the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH) as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. (scienceboard.net)
Through a systematic review and meta-analysis, researchers in the Early Detection, Prevention, and Infections Branch at IARC determined that of 734 women with moderate to advanced cervical intraepithelial neoplasia (CIN) who received therapeutic HPV vaccines, 54% showed regression of their lesions. (who.int)
The World Health Organization (WHO) is currently developing product performance characteristics (PPCs) for therapeutic HPV vaccines, through a consultative and iterative process with global partners including the Bill & Melinda Gates Foundation. (who.int)

Trials of palliative care interventions should consider multiple, mixed method, primary outcomes and ensure that protocols limit potential contaminating therapeutic effects in study designs. (figshare.com)
NIMH seeks applications for pilot projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. (nih.gov)
and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. (nih.gov)
When designing online interventions, it is important to adapt the therapeutic content to the values and needs of the target group. (jmir.org)
A participatory design process for designing online mental health interventions can be used to probe and balance between the therapeutic principles defined by clinicians and the participants' experiences with mental health issues in the production of therapeutic content. (jmir.org)

Patient and public involvement (PPI) is a form of research that is done "with" or "by" patients and members of the public, and is essential in shaping a subsequent Randomised Control Trial (RCT) to test psychedelic-assisted therapies. (frontiersin.org)
This clinical research network will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. (nih.gov)
The purpose of the network is to efficiently conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, and to facilitate collaborations between academia, industry, non-profit foundations, government organizations, and other possible stakeholders. (nih.gov)
The idea behind the ACTIV trial program is that multiple therapies can be tested within the same trial protocol over time (and dropped if not effective) and compared with the same placebo group without having to restart the trial each time. (clinicalomics.com)
ACTIV 2 is looking into therapies such as monoclonal antibodies but focusing on patients with less severe disease who are not hospitalized and assessing if such treatments can reduce severity and duration of symptoms. (clinicalomics.com)
ACTIV 3, which the AstraZeneca antibody combination trial forms part of, is testing monoclonal antibodies and other therapies for hospitalized patients with COVID-19. (clinicalomics.com)
ACTIV 5 trials are aiming to assess if therapies approved for other indications or drugs in late-stage development could also be used to treat COVID-19. (clinicalomics.com)
There are therapies being tested in clinical trials, some in GI cancers and pancreatic, and they are shifting towards a multimodality approach including the use of nutrition, exercise, and of a drug to combat the anorexia, hyper-metabolism, and muscle wasting associated with cancer. (cholangiocarcinoma.org)
The use of genetic data holds great promise for predicting disease risk or determining optimal therapies, but it must be put to the test through clinical trials like this one to determine how to best use that information," said Gary H. Gibbons, M.D., director of the NHLBI. (nih.gov)
Oncology researchers have seen an increase in responses in many diseases due to recent phase 1 clinical trials testing targeted therapies. (cancertherapyadvisor.com)
Recent phase 1 clinical trials testing targeted therapies have increased responses in many diseases in which other lines of therapy have failed. (cancertherapyadvisor.com)

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)
Its chapters, contributed by internationally renowned methodologists experienced in clinical trials, address topics that include Bayesian methods for phase I clinical trials, adaptive two-stage clinical trials, and the design and analysis of cluster randomization trials, trials with multiple endpoints, and therapeutic equivalence trials. (freepdfbook.com)
An analysis of these pivotal endpoints led to the conclusion that these may or may not correlate with practical treatment goals in real-world clinical practice. (medpagetoday.com)
In dermatology, discrepancy between pivotal trial endpoints and patient treatment goals may be particularly common according to an analysis by Wei and colleagues, which examined five specific disease states: actinic keratosis, acne vulgaris, atopic dermatitis, onychomycosis, and cutaneous ulcers. (medpagetoday.com)

However, patient-reported outcomes were characterized as a key component of clinical evaluation of atopic dermatitis, and these outcomes were not part of the primary end point in many of the pivotal trials. (medpagetoday.com)
Does CDC have data on long-term outcomes for patients enrolled in the clinical trial? (cdc.gov)

participants may have experienced a therapeutic effect from the research interviews, diluting the intervention's impact. (figshare.com)
During the first five days of therapy, the participants would have their dosages determined and adjusted by a clinical formula or a pharmacogenetic formula. (nih.gov)
Among the 255 African-American participants, the pharmacogenetic formula provided only 35.2 percent time in therapeutic range compared to 43.5 percent for the clinical formula. (nih.gov)
In the second phase, participants (n=109) gave feedback on the videos as part of a clinical trial of the intervention. (jmir.org)
In the first phase, the participants with ADHD contributed with experiences from challenging everyday situations. (jmir.org)
In the process, we navigated between therapeutic principles and the participants' experiential perspectives to create content relevant and consistent with the target group's values and experiences. (jmir.org)
In the second phase, we identified 3 themes related to the participants' experiences and interpretation of the video vignettes: (1) recognition of ADHD-related challenges, (2) connection with the characters and the situations, and (3) video protagonists as companions and role models for change. (jmir.org)
Participants will be randomly assigned to receive either two 100-microgram injections of mRNA-1273 or two shots of a saline placebo. (scienceboard.net)
Participants were followed-up in the trial for 18 months after randomization. (cdc.gov)
Infusion of autologous OTQ923 into three participants with severe sickle cell disease resulted in sustained induction of red-cell fetal hemoglobin and clinical improvement in disease severity. (cdc.gov)
In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. (who.int)
RÉSUMÉ Les études ayant examiné le processus du consentement éclairé chez les participants à des études de recherche dans les pays en développement sont peu nombreuses. (who.int)
The sample size ranged from two to 19 participants. (bvsalud.org)

Such regimens are likely to utilize both repurposed drugs and new chemical entities, and several of these regimens are now progressing through clinical trials. (nih.gov)
The trials assessed two Cosentyx dose regimens across 16-week (vs placebo) and 52-week treatment periods. (novartis.com)
The article, " Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis ," published in the New England Journal of Medicine (NEJM) , details findings from Study 31/A5349 - an international, randomized, controlled, open-label, phase 3 noninferiority clinical trial. (cdc.gov)

ADCs and CAR‑Ts could alter the therapeutic framework for refractory cancers, especially diffuse‑type gastric cancer, ovarian cancer and pancreatic cancer with peritoneal dissemination. (spandidos-publications.com)
September 27, 2007 - Genmab A/S (OMX: GEN) announced today it has amended the design of an ongoing pivotal study of ofatumumab (HuMax-CD20®) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL) to a single arm trial that will now include approximately 81 patients. (iex.nl)
In order to establish that ofatumumab is efficacious in this refractory setting, reducing the number of patients in the trial will help to expedite a result. (iex.nl)

Hyperkalemia in CKD: an overview of available therapeutic strategies. (qxmd.com)

Development of Spleen Tyrosine Kinase (SYK) negative allosteric modifiers for therapeutic intervention in Alzheimer's disease. (sbir.gov)
This FOA supports pilot research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. (nih.gov)
We report on the qualitative data from 2 research phases: the design and evaluation of video vignettes for an online intervention. (jmir.org)
In the first phase, 12 adults with ADHD, 2 clinicians, and 2 research assistants participated in the production of video vignettes for the online intervention. (jmir.org)
only 2 patients required surgical intervention for local progression or symptoms. (medscape.com)

The American Society of Clinical Oncology (ASCO) meeting took place in Chicago the first week of June. (cholangiocarcinoma.org)
In the modern era of oncology treatment, phase 1 clinical trials are sometimes the most valuable therapeutic option for patients who progress despite standard of care therapy for their disease. (cancertherapyadvisor.com)
In 2007, the American Society of Clinical Oncology (ASCO) updated the recommendations for the use of tumor marker tests in the prevention, screening, treatment, and surveillance of breast cancer. (medscape.com)

Design Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. (bmj.com)

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics . (medscape.com)

If these studies are successful, the alliance will select antibody programs for preclinical and clinical development. (beursonline.nl)
The preclinical and clinical data on PTC124 support our hope that this drug will be an important disease-modifying therapy for cystic fibrosis," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. (cff.org)

On page 6, Ali Abbara and Waljit Dhillo review our understanding of kisspeptin's role in puberty, with exciting potential developments in its therapeutic and diagnostic use. (eurospe.org)

SAN FRANCISCO, CA / ACCESSWIRE / September 15, 2021 / iPharma Labs, Inc. ("iPharma"), a privately-held contract development research organization (CDRO) specializing in inhalation pharmaceutical development services, announced today the implementation of GMP services for release testing for inhalation clinical trials (phase 1 - 2). (accesswire.com)
The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021. (medscape.com)
The clinical trial was recognized as one of the NEJM's 2021 Notable Articles . (cdc.gov)

Ongoing anti-cancer gene therapy clinical trials have highlighted the need for more efficient and safer vectors. (europa.eu)
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)
In addition, the network will serve as the vehicle for the conduct of early clinical trials of gene therapy for ultra-rare neurological disorders. (nih.gov)
In the bigger picture, these new treatment options need to be weighed against the possibility of cure of hemophilia through gene therapy: two adeno-associated virus (AAV) vector-based products have been approved for clinical use, and more are in the pipeline. (cdc.gov)

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)
For acne vulgaris, one of the objective clinical end point recommended by the FDA and utilized in pivotal trials is a significant change in 2 of 3 types of lesion counts (inflammatory, noninflammatory, or total), but Wei et al cautioned that lesion counts do not necessarily capture change in the lesions of greatest concern, such as a cyst/pustule relative to a comedone. (medpagetoday.com)
The objective of the present study was to conduct a systematic review of the treatment alternatives for the absence of interdental papilla (AIP), a clinical situation that can have aesthetic and phonetic impacts. (bvsalud.org)

Methods This was a single-centre Phase III fast-track single-blind mixed method RCT of BIS versus standard care for breathless patients with non-malignant conditions and their carers. (figshare.com)

Thanks to Truc Le, our Chief Compliance Officer, we have advanced our GMP capabilities and are excited that we can now offer release testing for early-stage clinical trials. (accesswire.com)

My name is Patricia Tang, I'm a medical oncologist at the Tom Baker Cancer Centre in Calgary, Alberta, Canada, and I'm a clinical associate professor in the medical school. (hstalks.com)
One Research Fellowship of €125 000 is available to support up to 2 years of research training in a centre of excellence, for those intending to pursue a career in paediatric endocrinology. (eurospe.org)

The turning point in medication development that resulted in the rigorous, regimented development of clinical trials in the United States occurred in 1937 when pharmaceutical manufacturer S.E. Massengill Company (Bristol, Tennessee) released the first elixir formulation of sulfanilamide, an antibiotic that, at the time, had been shown to have activity against strep-tococcal throat infections. (cancertherapyadvisor.com)
[ 2 ] This course is so rigorous that for every 5,000 to 10,000 compounds that enter preclinical testing, only one is approved for marketing. (medscape.com)

Increased travel distance to a cancer treatment facility negatively impacts the likelihood that patients with stage II/III rectal cancer will receive radiation therapy (RT) to treat their disease, according to a study analyzing 26,845 patient records. (sciencedaily.com)
Standard treatment for stage II/III rectal cancer, as outlined in National Comprehensive Cancer Network (NCCN) guidelines, includes RT, chemotherapy and surgery (i.e., trimodality therapy), yet as this retrospective study of NCDB patient records indicates, many eligible patients do not receive RT to treat their cancer. (sciencedaily.com)
This Phase-1 study has generally confirmed expectations. (cholangiocarcinoma.org)
Given the lack of definitive information on whether or not pharmacogenetics can improve the care of patients and the need to study a broad range of patients being treated with warfarin, we needed a large clinical trial like COAG to help resolve this important question," said Stephen Kimmel, M.D., of the Perelman School of Medicine at the University of Pennsylvania and principal investigator of the COAG trial. (nih.gov)
Study investigators compared how much time the patients spent in their ideal therapeutic dosage range during the 28-day monitoring phase. (nih.gov)
In part I of the study, Pts were enrolled in sequential dose cohorts of 0.5 mg/kg, 1mg/kg, 2 mg/kg, and 4 mg/kg to receive weekly intravenous dose of BNZ-1 to characterize safety, pharmacokinetics, pharmacodynamics, and evidence of antitumor activity. (confex.com)
Ocuphire Pharma Inc. is marching ahead despite falling short of the primary endpoint in top-line data from the Zeta-1 phase II study testing oral APX-3330 in diabetic retinopathy (DR). The trial did not achieve its goal with regard to the percentage of patients with a ≥2-step improvement in Diabetic Retinopathy Severity Score at week 24 in the study eye. (bioworld.com)
1 In a phase 3 study, this definition of complete cure was achieved in 17.8% of patients treated with efinaconazole solution versus 3.3% treated with vehicle. (medpagetoday.com)
To develop an accurate, easily assessable prognostic tool, researchers performed gene expression analyses using multiple microarray kits on samples from the University of Texas MD Anderson Cancer Center (MDACC) training cohort of 101 patients and an independent validation cohort from the German Chronic Lymphocytic Leukemia Study Group CLL8 trial of 109 patients. (medpagetoday.com)
How can you ensure that you're correctly digesting a clinical study? (healthtrustpg.com)
A clinical study is a medical observation or experiment done on people to learn more about the effects of a behavior, product or procedure. (healthtrustpg.com)
A clinical study may be funded by a number of entities, with the most common sources being governmental and private industry," says Moore. (healthtrustpg.com)
Controlled: The study has two groups for the purpose of comparing their results. (healthtrustpg.com)
Retrospective: A study that looks in the past to examine two similar groups where one group has a disease or condition, or exposure to a particular substance, and the other does not have the disease, condition or exposure. (healthtrustpg.com)
Moderna has finalized phase III clinical study protocols for its mRNA-1273 COVID-19 vaccine candidate in coordination with the U.S. Food and Drug Administration. (scienceboard.net)
Moderna released interim clinical data about mRNA-1273, its vaccine candidate against SARS-CoV-2, from the phase I study led by the U.S. National Institute. (scienceboard.net)
This guidance is based on an international phase 3 clinical trial (Study 31/A5349), preclinical/animal evidence, prior clinical trial findings, and pharmacokinetic and pharmacodynamic modeling. (cdc.gov)
This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. (who.int)
As studies with a randomized clinical trial design are not conducted to respond to this clinical question, the results of the present study should be used with caution. (bvsalud.org)

Twenty-four trials involving more than 6600 patients, phase II studies that reported on withdrawals from therapy (the most reliable indicator of adverse effects), and all studies reporting on quality of life were abstracted. (nih.gov)
Because of the extensive data already available on fluticasone, NCX 4251 would be expected to go directly into phase 2 clinical trials following toxicity studies and IND filing, pending IND approval by the FDA. (nicox.com)
The success of Vesneo™ in Phase 3 clinical studies has underlined the therapeutic interest of our nitric oxide donors in ophthalmology. (nicox.com)
We also have a portfolio of mechanistic studies, which are funded as 'bolt-ons' to existing late phase clinical trials. (nihr.ac.uk)
Pivotal studies defining our current standard of care will be highlighted, as will key ongoing trials that may influence our management of glioblastoma in the near future. (cancernetwork.com)
Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. (prnewswire.com)
2 Stars Contradictory, insufficient, or preliminary studies suggesting a health benefit or minimal health benefit. (peacehealth.org)
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)
Based on these studies, dosing formulas have been developed that incorporate a person's genetic profile along with the patient's clinical characteristics to try and better predict the proper dose of warfarin - an approach known as pharmacogenetics. (nih.gov)
small clinical studies and some observational data have produced conflicting results. (nih.gov)
The next step is IND-enabling studies for its lead ophthalmology candidate, with clinical testing slated to start in 2024. (bioworld.com)
And they've all come to fruition thanks to clinical studies. (healthtrustpg.com)
Clinical studies are the foundation on which modern medicine is built. (healthtrustpg.com)
What are the types of clinical studies? (healthtrustpg.com)
Who conducts clinical studies? (healthtrustpg.com)
Who pays for clinical studies? (healthtrustpg.com)
Basel, September 10, 2022 - Novartis announced the results from two pivotal, Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx ® (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa (HS) with a favorable safety profile 5,6 . (novartis.com)
In data pooled from the two studies, the 300 mg dose of Cosentyx given every two weeks proved statistically superior to placebo in reducing skin pain, the most bothersome symptom of HS 1,8 . (novartis.com)
We look forward to further evaluating PTC124 in registration-directed clinical trials in both CF and DMD this year, as well as in studies in additional genetic disorders in the future. (cff.org)
There are several stages that precede the clinical trial phase of nanomedicine research, including the production of the raw nanomaterial s, synthesis of the pharmaceutical in a lab or manufacturing setting, and preclinical drug studies in animals and in vitro. (cdc.gov)
Two studies treated AIP with reticulated hyaluronic acid gel. (bvsalud.org)
Two studies did not describe the results numerically. (bvsalud.org)

iPharma is an inhalation contract development research organization (CDRO) founded in 2016 by a group of former employees of Inhale/Nektar Therapeutics, where they learned how to formulate a wide variety of therapeutic agents for inhalation delivery with state of the art technologies including hydrophobic and hydrophilic small molecules, peptides, large proteins (i.e. monoclonal antibodies), controlled release particles, RNAi, gene delivery constructs, and live viruses. (accesswire.com)
AZD7442 is a combination of two long-acting antibodies developed from the serum of patients who recovered from SARS-CoV-2 infection. (clinicalomics.com)

Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group ( P = .03). (medscape.com)
While patient selection continues to be a challenge for researchers who are conducting trials, the issue has been eased by thee introduction of prognostic models that assist oncologists and health care professionals in determining patients that would be most likely to benefit from trial participation have. (cancertherapyadvisor.com)
After optimizing the clinical utility of the app at the Family Health Centers at NYU Langone in May, the researchers aim to roll it out nationwide in the coming weeks. (bio-itworld.com)
Researchers at Colorado State University attempted to use riboflavin and ultraviolet light to reduce the SARS-CoV-2 virus in infected human plasma and whole-blood products . (bio-itworld.com)
Researchers will collect and analyze blood samples to detect and quantify immune responses to SARS-CoV-2. (scienceboard.net)

The good news for the cholangiocarcinoma community, was Mitesh Borad's updated results from the ongoing Phase 1/2 trial of RLY-4008 against FGFR2-altered CCA and other cancers ( NCT04526106 ). (cholangiocarcinoma.org)

1 Center for Clinical Microbiology, Division of Infection and Immunity, University College London Royal Free Campus, Rowland Hill Street, London NW3 2PF, UK. (nih.gov)
Phase II: $1,500,000 for up to 3 years Page 118 Background Over 60 million people in the U.S. have genital herpes which is caused by infection with herpes simplex virus type 1 or 2 (HSV-1, HSV-2). (sbir.gov)
Other discussions explore Bayesian reporting, methods incorporating compliance in treatment evaluation, and statistical issues emerging from clinical trials in HIV infection. (freepdfbook.com)
The Public Health Service (PHS) has recommended using antiretroviral drugs to reduce the acquisition of HIV infection among persons exposed in the workplace (e.g., accidental needlesticks received by health-care workers) (1,2). (cdc.gov)

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)
When determining an initial dose, doctors often start with a standard dose and can take certain clinical indicators into account to alter that dose. (nih.gov)
Recent research has suggested that variants of two genes, CYP2C9 and VKORC1, may be important in selecting the dose of warfarin needed for individual patients. (nih.gov)
African-Americans in the pharmacogenetic group generally took longer to reach an ideal dose compared to the clinical group (70 percent in the pharmacogenetic group reached their ideal range by day 14 compared to 87 percent in the clinical group). (nih.gov)
Riboflavin and UV light reduced the infectious titer of SARS-CoV-2 below the limit of detection for plasma products at 60-100% of the recommended energy dose. (bio-itworld.com)

Based on the positive phase 3 results for Vesneo™ and increased interest in the potential of nitric oxide (NO)-donors in ophthalmology, Nicox's Board of Directors has selected NCX 470 as the Company's lead follow-on glaucoma candidate for internal development. (nicox.com)

The therapeutic approach to renal cell carcinoma (RCC) is guided by the probability of cure, which is related directly to the stage or degree of tumor dissemination. (medscape.com)
These limitations on the dissemination of information have become a major topic of controversy in recent years. (medscape.com)

In the future we will offer release testing for late-stage clinical trials as well as manufacturing of clinical materials for custom inhalation formulations. (accesswire.com)

This paper provides a description of the types of potential nanomedicine exposures, the existing oversight framework for handling worker and third-party exposures, the deficiencies of that framework in clinical and residential settings, and possible new approaches to oversight. (cdc.gov)

Phase III clinical trials of Rova‑T for patients with small‑cell lung cancer and a phase III clinical trial of nirogacestat for patients with desmoid tumors are ongoing. (spandidos-publications.com)
OncotypeDX can help decisions in patients with tumors between 1 and 2 cm. (medscape.com)

ROCKVILLE, MD - The first patients have been dosed in a multi-regional Phase IIB randomized, placebo-controlled clinical trial for the treatment of hepatitis B-associated liver cancer. (nfcr.org)

Phase II: $1,500,000 for up to 3 years Background There is an urgent need for new therapeutics products for treating pulmonary diseases caused by mycobacteria. (sbir.gov)
Ribon Therapeutics operates as a clinical-stage biotechnology company. (cbinsights.com)
Brought to you by Atamparib is under clinical development by Ribon Therapeutics and currently in Phase II for Breast Cancer. (cbinsights.com)
We are pleased to have successfully completed this important portion of our VK5211 clinical development program, which confirms prior data from healthy young men and allows us to move rapidly into our planned Phase 2 hip fracture trial," said Brian Lian , Ph.D., chief executive officer of Viking Therapeutics. (prnewswire.com)

In 2017, we look forward to initiating clinical trials for the treatment of both cocaine and alcohol use disorders. (prnewswire.com)
This off-label use includes treatments for disorders not formally reviewed by the FDA, dosages or delivery mechanisms not approved by the agency, or use of the agents in patient populations not tested in FDA approved clinical trials. (medscape.com)

ii) gutless adenoviral vectors, by genetic modifications of the fibre and hexon proteins of the adenoviral capsids, as well as through the use of combined cell type specific and inducible promoters. (europa.eu)
Combining genetic data with clinical information to determine the initial dosage of the blood thinner warfarin, used to prevent blood clots in the circulatory system, was no more effective in achieving stable anticoagulation than using only clinical information, according to a National Institutes of Health-funded clinical trial. (nih.gov)
This is especially true for complex drugs like warfarin whose action in our bodies is influenced by a variety of genetic, clinical and environmental factors. (nih.gov)
Using Fate-seq, the team identified a SARS-CoV-2 genetic fragment that may enhance survival of the virus and appears-in predictive models-to be very stable. (bio-itworld.com)
Genetic basis for clinical response to CTLA-4 blockade in melanoma. (msdmanuals.com)

For onychomycosis, one of the primary end points recommended by the FDA is complete cure, which is achieved when there is a total lack of clinical evidence of onychomycosis (including lack of onycholysis and subungual hyperkeratosis). (medpagetoday.com)
This can in part be explained by the relative lack of clinical trials evaluating the multitude of therapeutic options for any given dermatologic condition. (medscape.com)

At the forefront of phase 1 clinical trials is the safety of every patient participant, which is particularly true when testing new oncologic treatments in which patients may risk potentially toxic treatments in the hope of slowing the progression of or even curing their disease. (cancertherapyadvisor.com)

The phase III blinded trial will evaluate the safety of mRNA-1273 and determine if the vaccine can prevent symptomatic COVID-19 after two doses. (scienceboard.net)

The basis of regulatory approval of pharmaceutical agents employed in specific dermatologic diseases is relevant for real-world clinical choices and expectation of benefit. (medpagetoday.com)
The National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health (NIH), has established a new clinical trials. (scienceboard.net)
The off-label use of drugs has significantly contributed to the therapeutic armamentarium of many different diseases in medicine. (medscape.com)
Hot Topics of the Day are picked by experts to capture the latest information and publications on public health genomics and precision health for various diseases and health topics. (cdc.gov)

Filorexant was studied for but was not found to be effective in the treatment of diabetic neuropathy, migraine, and major depressive disorder in phase 2 clinical trials. (wikipedia.org)
Seltorexant is under development for treatment of major depressive disorder however and is in phase 3 trials for this indication. (wikipedia.org)
Completion of this transaction launches Amygdala Neurosciences with a Phase-2 ready asset that we believe has the potential to become a treatment for addiction," said Peter Strumph , Amygdala's co-founder and CEO. (prnewswire.com)
It "may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents," the authors wrote. (medscape.com)
VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) entering Phase 2 development for the treatment of patients recovering from non-elective hip fracture surgery. (prnewswire.com)
In Phase 1 clinical trials, VK5211 demonstrated statistically significant increases in lean body mass among treated subjects following 21 days of treatment. (prnewswire.com)
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 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)
whilst both may present with similar clinical features, they are best considered as distinct disease entities since the underlying pathophysiology and treatment strategies are very different. (dovepress.com)
While patient safety is always a chief concern within a clinical trial, some patients fear the risk of participating in experimental treatment. (cancertherapyadvisor.com)
While there are certainly risks for patients enrolled in a phase 1 trial, the benefit of treatment response in the era of rational, targeted therapy is increased when compared with the era of cytotoxic therapy. (cancertherapyadvisor.com)
Both trials previously confirmed that chemoimmunotherapy with FCR was effective as upfront treatment for CLL. (medpagetoday.com)
We are excited about the start of multi-country Phase II clinical trials for YIV-906 and optimistic about its potential to improve the lives of cancer patients, as well as its vanguard role in possibly ushering in a new era of treatment-a convergence of Western and Eastern medicines" said NFCR President and CEO Sujuan Ba, Ph.D. (nfcr.org)
The treatment of metastatic RCC is problematic, so whenever possible, patients should be directed to approved and controlled clinical trials. (medscape.com)
Go to Renal Cell Carcinoma Treatment Protocols , Clear Cell Renal Cell Carcinoma , and Sarcomatoid and Rhabdoid Renal Cell Carcinoma for complete information on these topics. (medscape.com)
However, there are only limited treatment options available that can make a difference to people living with this debilitating disease," said Dr. Alexa B. Kimball, lead investigator of the trials, investigator at Beth Israel Deaconess Medical Center, and Professor of Dermatology, Harvard Medical School. (novartis.com)
These Phase III data have been submitted to regulatory authorities in Europe and will be submitted to regulatory authorities in the United States this year, with the goal of bringing Cosentyx as a new treatment option to patients living with HS as soon as possible. (novartis.com)
It has an intensive phase of 8 weeks, followed by a continuation phase of 9 weeks (total 17 weeks for treatment). (cdc.gov)
The substitution of these two drugs (i.e., rifapentine for rifampin, and moxifloxacin for ethambutol) in the standard 6-month RIPE regimen (i.e., rifampin, isoniazid, pyrazinamide, and ethambutol) made it possible to reduce the duration of treatment for drug-susceptible pulmonary tuberculosis to four months. (cdc.gov)

The completion of dosing in the first cohort of our GALILEO-1 trial of FLT201 represents a significant milestone for the program, for Freeline and for the Gaucher community. (freeline.life)
Today, Freeline announced the dosing of the second patient in its GALILEO-1 trial of FLT201, marking the completion of dosing in the first cohort. (freeline.life)

Our GBA1-linked Parkinson's disease program is a natural extension of our work in Gaucher and an opportunity to extend the therapeutic potential of our longer-acting GCase variant into a genetically defined patient population with a serious unmet need. (freeline.life)
Pre-clinical and clinical evidence suggests that psychedelic therapy has acute and sustained therapeutic potential, and can be used to treat chronic pain and anorexia nervosa. (frontiersin.org)
Viking believes that VK5211 has the potential to produce the therapeutic benefits of testosterone with improved safety, tolerability and patient acceptance due to a tissue-selective mechanism of action and an oral route of administration. (prnewswire.com)
Within this article, Amit Mahipal, MD, and Danny Nguyen, MD, explore both the risks and the potential for benefit for patients with cancer who participate in clinical trials. (cancertherapyadvisor.com)

As an example, Dr. Sallman has focused research and clinical trial efforts on patients who have TP53 mutation (often associated with complex genes/cytogenetics) given their high risk of transformation to acute leukemia and poor survival. (moffitt.org)
A common suicide/reporter gene will first be used for all vectors, and then additional therapeutic genes will be tested. (europa.eu)
3] Patients are classified into one of two distinct categories based on the presence or absence of mutations in the IDH1 or IDH2 genes. (cancernetwork.com)

Evidence from 8 trials involving 2717 patients suggests that nonsteroidal antiandrogens were associated with lower overall survival. (nih.gov)

Phase I and II clinical trials) for patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) based on the underlying mutational drivers of each disease. (moffitt.org)

This report reviews the topics raised at the meeting, provides background information on patient management options, and presents considerations for antiretroviral therapy. (cdc.gov)

Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception. (who.int)

The NCX 667 results were selected by the ARVO 2015 Annual Meeting Program Committee as a 'Hot Topic', representing the newest and most innovative research being conducted 3 . (nicox.com)
This therapeutic approach results in highly targeted editing of the HSC's DNA to induce fetal hemoglobin (HbF) expression. (medjournal360.com)
The results of the Clarification of Optimal Anticoagulation through Genetics (COAG) trial, supported by the NIH's National Heart, Lung, and Blood Institute, were presented today at the American Heart Association (AHA) Scientific Sessions in Dallas. (nih.gov)
The results from phase 1 clinical trials can allow new treatments to progress further in drug development or halt that process altogether. (cancertherapyadvisor.com)
Results from clinical trials help to answer questions and provide guidance for practicing health care pro-fessionals. (cancertherapyadvisor.com)
Ocuphire plans to schedule an end-of-phase II meeting with the U.S. FDA to review the results. (bioworld.com)
Results showed a significantly higher proportion of patients achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) when treated with Cosentyx 300 mg, dosed every two weeks (after standard weekly loading doses), compared with placebo at Week 16 in both the SUNSHINE and SUNRISE trials (45.0% vs 33.7% [P=.0070] and 42.3% vs 31.2% [P=0.0149], respectively) 1 . (novartis.com)
The interim guidance is based on results of an international phase 3 clinical trial sponsored by CDC's Tuberculosis Trials Consortium and conducted in collaboration with the National Institutes of Health-sponsored AIDS Clinical Trials Group. (cdc.gov)
It was concluded that the therapeutic results presented by the authors were positive. (bvsalud.org)

For actinic keratosis, the primary endpoint required for clinical trials is 100% clearance of lesions in the area (typically 25cm 2 ) of topical application. (medpagetoday.com)

Ten trials of LHRH agonists involving 1908 patients reported no significant difference in overall survival. (nih.gov)
He has published significantly on this topic including recently in highly regarded journals including Leukemia and Haematologica and these work form the foundation of the clinical trials that he is bringing to patients in order to improve their quality of life and survival. (moffitt.org)

These clinical measures include age, body size, smoking status, and use of certain medications. (nih.gov)
It will be recruiting hepatitis B-associated liver cancer patients for twenty clinical sites, include Memorial Sloan Kettering Cancer Center, National Cancer Center of China, Taipei Medical University and Queen Mary Hospital in Hong Kong. (nfcr.org)

The number of drugs that are successful through each phase of drug development decreases. (hstalks.com)
Smarter leaders trust GlobalData GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. (cbinsights.com)
Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. (cbinsights.com)
for others, the therapeutic gain required for drug approval might not be fully relevant to the result sought by a patient. (medpagetoday.com)
Being tested in the first line setting is a first-in-class botanical drug candidate, YIV-906 (also known as PHY906 and KD018), whose development has been supported by the National Foundation for Cancer Research (NFCR) for two decades. (nfcr.org)
If, following these and future Phase III trials, the drug is approved by the U.S. Food and Drug Administration (FDA), it would be the country's first authorization for usage of a purely botanical cancer drug and usher in a new paradigm for drug discovery. (nfcr.org)
Over the past two decades and with NFCR support, Dr. Cheng has transitioned his focus from small molecule to botanical drug discovery. (nfcr.org)
Recent policy changes on the regulatory abilities of the US FDA and legal precedents regarding this topic have led to intense debate on free speech about off-label drug use by physicians and drug manufacturers. (medscape.com)

This review focuses on clinical developments and management of newly diagnosed glioblastoma, and includes a discussion about the incorporation of molecular features into the classification of this disease. (cancernetwork.com)
2] Glioblastoma is histologically defined by neoplastic cells with astrocytic characteristics and the presence of either endothelial proliferation-often in a glomeruloid morphology-and/or necrosis, which may resemble a pseudopalisading pattern (a false fence of neoplastic cells surrounding an area of necrotic tissue). (cancernetwork.com)
Neoantigen vaccine generates intratumoral T cell responses in phase Ib glioblastoma trial. (msdmanuals.com)

We look forward to reporting initial clinical data in the third quarter of this year. (freeline.life)
The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite applications to participate as a Data Coordinating Center (DCC) in the Network for Excellence in Neuroscience Clinical Trials. (nih.gov)
This funding opportunity announcement invites applications for participation as the Data Coordinating Center (DCC) in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). (nih.gov)
Selecting patients with cancer who will survive long enough to accrue data for these trials continues to be challenging. (cancertherapyadvisor.com)
Over the next two weeks, the team at NGM Biopharmaceuticals Inc. will be digging through the data from its phase II trial of complement 3 inhibitor NGM-621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration, following reports of a top-line miss Oct. 17 and a severe reaction from investors, who sent shares (NASDAQ:NGM) plummeting 70.5% to close at $3.41. (bioworld.com)
Their goal is to carefully validate the models deposited into the Protein Data Bank of CoV-2 proteins, with the aim of helping the biomedical community to establish a validated database. (bio-itworld.com)
In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health (NIH) data base, www.clinicaltrials.gov . (cdc.gov)

However, several antigens with selective expression on the surface of tumor cells are not associated with the major histocompatibility complex and may be candidates for therapeutic targeting. (msdmanuals.com)

Anatomy1

Organisms2

Diseases53

Chemicals and Drugs77

Analytical, Diagnostic and Therapeutic Techniques and Equipment79

Psychiatry and Psychology3

Phenomena and Processes11

Disciplines and Occupations6

Anthropology, Education, Sociology and Social Phenomena6

Technology, Industry, Agriculture2

Humanities1

Information Science7

Named Groups1

Health Care65

Geographicals3

Biomarkers6

Efficacy18

20233

20202

Investigational8

Vaccines3

Interventions5

Therapies11

Endpoints4

Outcomes2

Participants13

Regimens3

Refractory3

Available therapeutic1

Intervention5

Oncology3

Exploratory1

Multicenter1

Preclinical and clinical2

Diagnostic1

20213

Gene Therapy4

Objective4

Single-centre1

Early-stage clinical trials1

Centre2

Rigorous2

Study19

Studies22

Antibodies2

Researchers5

Cancers1

Infection4

Dose5

Ophthalmology1

Dissemination2

Late-stage clinical1

Approaches1

Tumors2

Placebo-controlled1

Therapeutics4

Disorders2

Genetic5

Lack of clinical2

Progression1

Evaluate1

Diseases4

Treatment19

Completion2

Potential4

Genes3

Evidence1

Acute1

CONSIDERATIONS1

Research and clinical1

Results9

Lesions1

Survival2

Include2

Drug8

Glioblastoma3

Data7

Tumor cells1