Search Results - "Clinical Trials, Phase I as Topic"

Sentinel dosing: A proposed algorithm to guide decision making on which cohorts in early phase clinical pharmacology trials should use this approach by Heuberger, Jules A. A. C., Jongh, Perry, Hoogdalem, Ewoud‐Jan, Tamminga, Wim, Graeff, Pieter, Groeneveld, Geert Jan

“…Aim The aim of this paper is to describe a proposal for an algorithm to guide decision making on which cohorts in early phase pharmacology trials should employ…”
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Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products by Gerven, Joop, Bonelli, Milton

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Low-dose mRNA-1273 COVID-19 vaccine generates durable memory enhanced by cross-reactive T cells by Mateus, Jose, Dan, Jennifer M, Zhang, Zeli, Rydyznski Moderbacher, Carolyn, Lammers, Marshall, Goodwin, Benjamin, Sette, Alessandro, Crotty, Shane, Weiskopf, Daniela

“…% of subjects, with equivalent memory at 6 months post-boost compared with COVID-19 cases. Lastly, subjects with preexisting cross-reactive CD4 T cell memory exhibited…”
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Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease by Hickson, LaTonya J., Langhi Prata, Larissa G.P., Bobart, Shane A., Evans, Tamara K., Giorgadze, Nino, Hashmi, Shahrukh K., Herrmann, Sandra M., Jensen, Michael D., Jia, Qingyi, Jordan, Kyra L., Kellogg, Todd A., Khosla, Sundeep, Koerber, Daniel M., Lagnado, Anthony B., Lawson, Donna K., LeBrasseur, Nathan K., Lerman, Lilach O., McDonald, Kathleen M., McKenzie, Travis J., Passos, João F., Pignolo, Robert J., Pirtskhalava, Tamar, Saadiq, Ishran M., Schaefer, Kalli K., Textor, Stephen C., Victorelli, Stella G., Volkman, Tammie L., Xue, Ailing, Wentworth, Mark A., Wissler Gerdes, Erin O., Zhu, Yi, Tchkonia, Tamara, Kirkland, James L.

“… In an open label Phase 1 pilot study, we administered 3 days of oral D 100 mg and Q 1000 mg to subjects with diabetic kidney disease…”
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Activity-based protein profiling reveals off-target proteins of the FAAH inhibitor BIA 10-2474 by van Esbroeck, Annelot C M, Janssen, Antonius P A, Cognetta, 3rd, Armand B, Ogasawara, Daisuke, Shpak, Guy, van der Kroeg, Mark, Kantae, Vasudev, Baggelaar, Marc P, de Vrij, Femke M S, Deng, Hui, Allarà, Marco, Fezza, Filomena, Lin, Zhanmin, van der Wel, Tom, Soethoudt, Marjolein, Mock, Elliot D, den Dulk, Hans, Baak, Ilse L, Florea, Bogdan I, Hendriks, Giel, De Petrocellis, Luciano, Overkleeft, Herman S, Hankemeier, Thomas, De Zeeuw, Chris I, Di Marzo, Vincenzo, Maccarrone, Mauro, Cravatt, Benjamin F, Kushner, Steven A, van der Stelt, Mario

“…A recent phase 1 trial of the fatty acid amide hydrolase (FAAH) inhibitor BIA 10-2474 led to the death of one volunteer and produced mild-to-severe…”
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EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins by Remon, Jordi, Hendriks, Lizza E.L., Cardona, Andres F., Besse, Benjamin

“…•EGFR exon 20 insertion mutations occur in ~2–3% of all NSCLC cases.•Activity of 1st to 3rd generation EGFR-TKI is less in EGFR ex20ins versus common…”
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"Paid to Endure": Paid Research Participation, Passivity, and the Goods of Work by Malmqvist, Erik

“… (other) jobs, too, and therefore proposed improving subject protections by regulating phase I trial participation as work…”
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Bedaquiline: a review of human pharmacokinetics and drug-drug interactions by van Heeswijk, R P G, Dannemann, B, Hoetelmans, R M W

“…) to a less-active N-monodesmethyl metabolite. Phase I and Phase II studies in healthy subjects and patients with drug-susceptible or multidrug-resistant TB have assessed the pharmacokinetics and drug-drug interaction profile of bedaquiline…”
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MGAT2 inhibitor decreases liver fibrosis and inflammation in murine NASH models and reduces body weight in human adults with obesity by Cheng, Dong, Zinker, Bradley A, Luo, Yi, Shipkova, Petia, De Oliveira, Claudia H, Krishna, Gopal, Brown, Elizabeth A, Boehm, Stephanie L, Tirucherai, Giridhar S, Gu, Huidong, Ma, Zhengping, Chu, Ching-Hsuen, Onorato, Joelle M, Kopcho, Lisa M, Ammar, Ron, Smith, Julia, Devasthale, Pratik, Lawrence, R Michael, Stryker, Steven A, Dierks, Elizabeth A, Azzara, Anthony V, Carayannopoulos, Leon, Charles, Edgar D, Lentz, Kimberley A, Gordon, David A

“…Monoacylglycerol acyltransferase 2 (MGAT2) is an important enzyme highly expressed in the human small intestine and liver for the regulation of triglyceride…”
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Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers by Neuzil, Petr, Exner, Derek V, Knops, Reinoud E, Cantillon, Daniel J, Defaye, Pascal, Banker, Rajesh, Friedman, Paul, Hubbard, Chris, Delgado, Stephanie M, Bulusu, Anuradha, Reddy, Vivek Y

“… Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6…”
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Tregs Attenuate Peripheral Oxidative Stress and Acute Phase Proteins in ALS by Beers, David R., Thonhoff, Jason R., Faridar, Alireza, Thome, Aaron D., Zhao, Weihua, Wen, Shixiang, Appel, Stanley H.

“…). Regulatory T lymphocyte (Treg) therapy was assessed for suppression of OS and APP responses in longitudinal serum samples from subjects with amyotrophic lateral sclerosis (ALS…”
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Randomised Phase 1 clinical trials in oncology by Iasonos, Alexia, O’Quigley, John

“…The aims of Phase 1 trials in oncology have broadened considerably from simply demonstrating that the agent/regimen of interest is well tolerated in a…”
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Safety, Tolerability, Pharmacokinetics, and Antimalarial Activity of the Novel Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048 in Healthy Volunteers by Sinxadi, Phumla, Donini, Cristina, Johnstone, Hilary, Langdon, Grant, Wiesner, Lubbe, Allen, Elizabeth, Duparc, Stephan, Chalon, Stephan, McCarthy, James S, Lorch, Ulrike, Chibale, Kelly, Möhrle, Jörg, Barnes, Karen I

“…MMV390048 is a novel antimalarial compound that inhibits phosphatidylinositol-4-kinase. The safety, tolerability, pharmacokinetic profile, and antimalarial…”
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First-in-human dose: current status review for better future perspectives by Mishra, Archana, Sarangi, Sudhir Chandra, Reeta, Kh

“… Subjects and methods We reviewed early phase clinical trials for methods of FIH dose and dose-escalation steps and discuss them in line with existing guidelines…”
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TITE‐BOIN‐ET: Time‐to‐event Bayesian optimal interval design to accelerate dose‐finding based on both efficacy and toxicity outcomes by Takeda, Kentaro, Morita, Satoshi, Taguri, Masataka

“…) that is both tolerable and has an indication of therapeutic benefit for subjects in subsequent clinical trials…”
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Participation in phase 1 trials for patients with cancer by Italiano, Antoine

“…[...]the treatment-related death risk always remained below 1% in all periods and across all cancers, except pancreatic cancer. [...]the sample size of…”
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HIF2 Inactivation and Tumor Suppression with a Tumor-Directed RNA-Silencing Drug in Mice and Humans by Ma, Yuanqing, Joyce, Allison, Brandenburg, Olivia, Saatchi, Faeze, Stevens, Christina, Toffessi Tcheuyap, Vanina, Christie, Alana, Do, Quyen N, Fatunde, Oluwatomilade, Macchiaroli, Alyssa, Wong, So C, Woolford, Layton, Yousuf, Qurratulain, Miyata, Jeffrey, Carrillo, Deyssy, Onabolu, Oreoluwa, McKenzie, Tiffani, Mishra, Akhilesh, Hardy, Tanner, He, Wei, Li, Daniel, Ivanishev, Alexander, Zhang, Qing, Pedrosa, Ivan, Kapur, Payal, Schluep, Thomas, Kanner, Steven B, Hamilton, James, Brugarolas, James

“…HIF2α is a key driver of kidney cancer. Using a belzutifan analogue (PT2399), we previously showed in tumorgrafts (TG) that ∼50% of clear cell renal cell…”
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Challenging Assumptions About Minority Participation in US Clinical Research by Fisher, Jill A., Kalbaugh, Corey A.

“…Although extensive research addresses minorities’ low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing…”
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Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction (MARSH): Study protocol for a phase 1 dose-escalation trial of patients with xerostomia after radiation therapy for head and neck cancer: MARSH: Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction by Blitzer, Grace C, Rogus-Pulia, Nicole M, Mattison, Ryan J, Varghese, Tomy, Ganz, Olga, Chappell, Richard, Galipeau, Jacques, McDowell, Kimberly A, Meyers, Ross O, Glazer, Tiffany A, Kimple, Randall J

“…Xerostomia, or dry mouth, is a common side effect of head and neck radiation. Current treatment options for radiation-induced xerostomia are generally…”
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Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology by Amin, Neeta B., Saxena, Aditi R., Somayaji, Veena, Dullea, Robert

“…Hepatic steatosis due to altered lipid metabolism and accumulation of hepatic triglycerides is a hallmark of nonalcoholic fatty liver disease (NAFLD)…”
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