ライフサイエンスコーパス: investigational

1 ic treatment of nongastric lymphomas remains investigational.

2 ction, followed by concomitant treatment, is investigational.

3 ia terminalis and nucleus accumbens) remains investigational.

4 Studies demonstrate that the investigational (64)Cu-DOTATATE radiopharmaceutical may

5 The investigational 9-valent viruslike particle vaccine agai

6 llografts was low in both control (9.5%) and investigational (9.1%) arms.

7 a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury.

8 ble liberal creatinine clearance, unless the investigational agent involves renal excretion.

9 patients in groups 2 and 3 who received the investigational agent or placebo.

10 Within a backup program for the clinical investigational agent pretomanid (PA-824), scaffold hopp

11 to Zaire ebolavirus in West Africa received investigational agent rVSV-ZEBOV or TKM-100802 for poste

12 comes confirmed clinician reporting that the investigational agent was well tolerated and, in subgrou

13 y cancer surgery are treated briefly with an investigational agent).

14 Investigational agents with novel mechanisms of action a

15 alance patient safety, access to appropriate investigational agents, and study integrity.

16 on of 304 inhibitors, including approved and investigational agents, comparing ex vivo responses of p

17 eceived uncontrolled treatment with multiple investigational agents, including convalescent plasma, w

18 Brigatinib (AP26113) is an investigational ALK inhibitor with potent preclinical ac

19 gnificance, although their use is considered investigational and has not been transferred to clinical

20 irate (28.4% and 20.7%, respectively), while investigational and prognostic FNABs were most likely to

21 Several investigational anti-CMV agents are under development, b

22 QGE031 is an investigational anti-IgE antibody that binds IgE with hi

23 s of the efficacy of currently available and investigational anti-influenza drugs.

24 for estimating the maximum tolerated dose of investigational anticancer agents is based on the cytoto

25 A number of established and investigational anticancer drugs slow the religation ste

26 Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spec

27 a lower specificity of 95.2% using a set of investigational antigens which are being further evaluat

28 Limited data for new investigational antimicrobials such as the ketolide soli

29 , we propose CPX and other iron chelators as investigational antitumor agents in NB therapy.

30 nd is a key focus of clinical trials of some investigational antiviral agents.

31 Our findings demonstrate the investigational application of single-cell RNA-seq in th

32 n-spine interface have all been approved for investigational applications in similar human research,

33 e been reported so far; to introduce such an investigational approach, we exploited the structural mo

34 basis for the current standards of care, and investigational approaches to treat or manage GBM.

35 While many investigational, approved, and repurposed drugs have bee

36 One subject in the investigational arm died with functioning pancreas and k

37 An investigational arm of paclitaxel plus lapatinib (TL) wa

38 ressive regimen (tacrolimus) (n = 21), or an investigational arm using low-dose CNI plus costimulatio

39 0%) in the control group and 19 (86%) in the investigational arm.

40 mycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the co

41 in the paclitaxel plus ART arm than in both investigational arms.

42 ) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (atten

43 cians' diagnoses, in-clinic assessments, and investigational-assay results were compared to gold stan

44 N. gonorrhoeae and C. trachomatis for three investigational assays compared to a composite reference

45 n of N. gonorrhoeae and C. trachomatis for 3 investigational assays compared to a composite reference

46 Overall, the investigational assays had higher sensitivity and specif

47 d in-clinic assessments, indicating that the investigational assays were more predictive of infection

48 idime-avibactam, and imipenem-relebactam (an investigational beta-lactam/beta-lactamase inhibitor).

49 s can identify RA-ILD and if the addition of investigational biomarkers is informative.

50 clinically, while patients who underwent an investigational biopsy all had an unequivocal or probabl

51 and immunogenicity in older US adults of an investigational bivalent C. difficile vaccine that conta

52 Ancillary radiologic and genomic tests are investigational but may have a role in patients with dis

53 how the inclusion of children in early-phase investigational cancer drug trials might be accomplished

54 setting also facilitates the examination of investigational cancer therapies, including new immunoth

55 iver, planned use of a biological agent, and investigational centre.

56 tment, i.e., the gold salt auranofin and the investigational chemotherapeutic agent buthionione sulfo

57 The investigational cigarettes had nicotine content ranging

58 specimens were imaged intraoperatively in an investigational CLI system.

59 ibitors culminating in identification of the investigational clinical candidate brigatinib.

60 text of, but not in the path of, routine and investigational clinical care for purposes of enabling d

61 ration epiretinal prosthesis approved for an investigational clinical trial by the United States Food

62 activism, clinical trial infrastructure, and investigational clinical trial designs as well as coordi

63 or to 28 September 2020 update), EUCAST, and investigational CLSI breakpoints (BPs).

64 MICs were interpreted according to the investigational CLSI, FDA, and EUCAST breakpoints, and r

65 This investigational compound is currently in phase 1 clinica

66 rats to study the efficacy and safety of the investigational compound that contained 20 mug/ml of nal

67 Remdesivir (RDV) is an investigational compound with a broad spectrum of antivi

68 stemological gradient that should also be an investigational continuum.

69 Maternal vaccination with an investigational CRM197-glycoconjugate GBS vaccine elicit

70 aemic men (BMI 25-35 kg/m(2)) underwent four investigational days, during which SCFA mixtures (200 mm

71 nal systemic therapy, were enrolled from 122 investigational dermatology centres worldwide.

72 B.b. sequence analysis was performed using investigational detection thresholds, different from Kar

73 We provide an in depth description of seven investigational device classes designed to target one or

74 e-arm Food and Drug Administration-regulated investigational device exemption clinical study.

75 ndovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is compr

76 ating the conduct of these studies under the Investigational Device Exemption regulations.

77 ney/snorkels and any devices implanted under Investigational Device Exemption studies.

78 The SUPERB Trial, an investigational device exemption study using an interwov

79 gator-initiated Food and Drug Administration Investigational Device Exemption study, we used a novel

80 ion-approved prospective physician-initiated investigational device exemption study.

81 with the retrograde technique in the LAMPOON investigational device exemption trial (39+/-09 versus 6

82 athable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), h

83 The US Investigational Device Exemption trial prospectively enr

84 30 days, similar to subjects in the LAMPOON investigational device exemption trial.

85 isk of fixed-LVOT obstruction in the LAMPOON investigational device exemption trial.

86 hypothesis in the multicenter randomized MPP investigational device exemption trial.

87 ntable cardioverter-defibrillator IDE study (Investigational Device Exemption), a successful conversi

88 This prospective, multicenter, investigational device exemption, single-arm trial enrol

89 is a single-site, multisurgeon, IRB-approved investigational device prospective study.

90 ctive consecutive case series regarding this investigational device.

91 Here, we review established and investigational diagnostic tests utilized for urogenital

92 assess the safety and immunogenicity of two investigational DNA vaccines, one (EBO vaccine) encoding

93 Eritoran is an investigational drug for sepsis treatment that resembles

94 The nucleotide analogue remdesivir is an investigational drug for the treatment of human coronavi

95 -class styrylbenzene based antibiotic, is an investigational drug indicated for Clostridium difficile

96 The mechanistically novel investigational drug ITI-007 was effective for the treat

97 No adverse reactions to the investigational drug product and no abnormal clonal prol

98 ung colonization could be abrogated using an investigational drug that attenuates Stat3 activity, imp

99 rolone is a first-in-class anti-inflammatory investigational drug that has shown evidence of efficacy

100 atitis C immunoglobulin (HCIG) Civacir is an investigational drug that is currently being developed i

101 an hepatitis C immune globulin Civacir is an investigational drug that is currently being developed i

102 ted to participate in a clinical trial of an investigational drug that is now widely used to treat br

103 This investigational drug was compared with the common antihy

104 .3-angstrom resolution and the other with an investigational drug, GLPG1837, at 3.2-angstrom resoluti

105 .3-angstrom resolution and the other with an investigational drug, GLPG1837, at 3.2-angstrom resoluti

106 The investigational drug, nivolumab, was administered intrav

107 reatment with a GlyT1 inhibitor or any other investigational drug.

108 ntral fat accumulation were recorded for the investigational drug.

109 019, evaluating the characteristics of these investigational drugs and the outcomes of these drug dev

110 his challenge by testing 128 FDA-approved or investigational drugs as either single agents or in 768

111 atory scrutiny that affects manufacturers of investigational drugs for early-phase clinical trials en

112 ccurately predict the safety and efficacy of investigational drugs in humans.

113 reveals potential drug targets, with several investigational drugs showing efficacy in vitro.

114 ibutes and limitations of recently disclosed investigational drugs targeting Na(V)1.7 and review evid

115 lines require that potential interactions of investigational drugs with P-gp be explored, often this

116 leading drug candidates, several designated investigational drugs, and some medical devices, as well

117 ating agents (HMAs), lenalidomide (LEN), and investigational drugs, may be used after ESA failure in

118 act as suitable carriers for the delivery of investigational drugs.

119 0 mg/kg of poractant alfa using a customized investigational eFlow-Neos nebulizer was found to be saf

120 (poractant alfa 400 mg/kg) via a customized investigational eFlow-Neos vibrating membrane nebulizer

121 he meantime, Phase III study results suggest investigational epicutaneous immunotherapy (EPIT) may be

122 for reversing the effects of dabigatran, the investigational factor Xa decoy andexanet alfa, and the

123 Margetuximab, a novel, investigational, Fc-engineered, anti-HER2 monoclonal ant

124 ascular, pulmonary, and renal complications, investigational focus has extended toward endothelial gl

125 static agents and surgical interventions are investigational for intracerebral haemorrhage.

126 Chan et al. describe a novel way by which an investigational form of chemotherapy known as low-dose m

127 Patients in the investigational group received the same treatment as the

128 trolled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal

129 a 15% non-inferiority margin to compare the investigational groups against the active control group.

130 vitro biocatalytic cascade synthesis of the investigational HIV treatment islatravir.

131 is the prodrug of temsavir, a first-in-class investigational HIV-1 attachment inhibitor.

132 TH-302 is an investigational hypoxia-activated prodrug that releases

133 to support FDA approval of a commonly cited investigational imaging agent.

134 Similarly, many investigational immunotherapy agents, which have shown p

135 Tisagenlecleucel (CTL019) is an investigational immunotherapy that involves reprogrammin

136 in 292 (33.2%), confirmatory in 121 (13.8%), investigational in 187 (21.3%), and prognostic in 280 (3

137 ety, and antiviral activity of ABI-H0731, an investigational inhibitor of the HBV core protein.

138 ) has been studied with two potent antiviral investigational inhibitors.

139 Non-inferiority of either investigational intervention was not shown, with paclita

140 e efficacy of our approach, we evaluated the investigational JAK2 inhibitor fedratinib (FED) in 64 pa

141 We highlight the investigational journey from patient phenotype to treatm

142 Investigational LDL cholesterol-lowering agents currentl

143 room temperature-stable, orally administered investigational live biotherapeutic.

144 xtraction, fecal specimens were processed by investigational lysis/heating (i.e., manual) and by chro

145 hoprim 5 mg/mL, ethanol 25%, and Ca-EDTA 3% (investigational medical device [IMD]) or heparin 5000 U/

146 Following withdrawal of the investigational medicinal product (IMP), 25 of the 28 pa

147 glucose regulation and may have potential as investigational metabolites to modify metabolic disease.

148 Concordance of investigational methods with automated extraction was >/

149 ls (GMVECs) and in HUVECs, a frequently used investigational model of endothelial cells.

150 its the algorithms, making them unusable for investigational molecules.

151 ng presentations illustrated established and investigational multimodal imaging features and associat

152 re, we evaluated bevacizumab and CRLX101, an investigational nanoparticle-drug conjugate containing c

153 tudy, we assessed the ability of CRLX101, an investigational nanoparticle-drug conjugate containing t

154 are currently being studied clinically under investigational new drug (IND) applications submitted to

155 Currently, investigational new drug (IND)-enabling studies with 1 a

156 orter of cGAMP and other CDNs, including the investigational new drug 2'3'-bisphosphosphothioate-cycl

157 s, as it promotes confidence in their use in Investigational New Drug and New Drug Application filing

158 ental vaccine available through an emergency Investigational New Drug application.

159 We present a longitudinal analysis of investigational new drug applications (INDs) for new, sy

160 the US Food and Drug Administration granted investigational new drug approval for the first phase 2A

161 Conducted under an investigational new drug authorization, we prospectively

162 Methods: Conducted under an investigational new drug authorization, we prospectively

163 eing treated on an expanded-access emergency investigational new drug basis.

164 eview of eligibility criteria for commercial investigational new drug clinical trial applications sub

165 ional review board, informed consent, and an Investigational New Drug Exemption, six healthy voluntee

166 BT-11 is an investigational new drug for IBD that is orally active,

167 The exploratory investigational new drug guidance describes early phase

168 the traditional Food and Drug Administration investigational new drug pathway.

169 e treated with HBAT under an expanded-access Investigational New Drug program.

170 trol specifications were established to meet investigational new drug submission and institutional re

171 At the time of the meetings, there were no investigational new drugs (INDs) in place for the candid

172 Of these, 65% are investigational new drugs, 17% are new drug applications

173 An investigational new eye drop containing 20 mug/ml NTX ef

174 imaged both eyes of preterm infants with an investigational noncontact, handheld swept-source (SS) O

175 Orteronel (TAK-700) is an investigational, nonsteroidal, reversible, selective 17,

176 efore and 4 weeks after administration of an investigational norovirus vaccine and were compared with

177 iding the discovery and development of novel investigational Notch-targeted therapeutics.

178 se (RdRp), which is the likely target of the investigational nucleotide analogue remdesivir (RDV).

179 with Flex module devices, both equipped with investigational OCTA software (Heidelberg Engineering, H

180 NAi therapeutics as well as other classes of investigational oligonucleotide therapeutics to the live

181 hine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive t

182 phine/samidorphan (BUP/SAM; ALKS 5461) is an investigational opioid system modulator for the adjuncti

183 tion, it may serve as a test bed to evaluate investigational opsonizing agents that might serve as th

184 r FDA-directed human testing and approval of investigational optical imaging devices as well as contr

185 pose To compare the diagnostic utility of an investigational optoacoustic imaging device that fuses l

186 Tucatinib is an investigational, oral, highly selective inhibitor of the

187 Orteronel is an investigational, partially selective inhibitor of CYP 17

188 Clear guidance is needed for the investigational pathway for TBM, including recommendatio

189 ar endothelial growth factor) throughout the investigational period.

190 (2S,4R)-4-fluoroglutamine ((18)F-FGln) is an investigational PET radiotracer for imaging tumor glutam

191 six, and only the study statistician and the investigational pharmacy had the preset randomisation as

192 potent HIV-1 capsid inhibitor GS-6207 is an investigational principal component of long-acting antir

193 in patients who had at least one dose of the investigational product (2241 patients with denosumab vs

194 For 354 patients who received >=1 dose of investigational product (placebo, n = 116; 7 mg, n = 21;

195 nteers began a thrice-daily, 7-day course of investigational product administered in sodium bicarbona

196 d patients who received at least one dose of investigational product and completed at least one post-

197 rticipants who received at least one dose of investigational product in FREEDOM or the extension were

198 vents (AEs) at least possibly related to the investigational product were classified by the investiga

199 g treatment or missing more than one dose of investigational product were eligible to enrol in the op

200 aratide group with adverse events leading to investigational product withdrawal.

201 nteractive response system to a double-blind investigational product, and stratified by previous expo

202 rticipants who received at least one dose of investigational product, whereas the efficacy analyses i

203 observed in 27 participants with no serious investigational product-related events.

204 We assessed data from a large-scale, investigational product-release screening and donor foll

205 d patients who received at least one dose of investigational product.

206 d patients who received at least one dose of investigational product.

207 Some of these investigational products have already been used under em

208 afety laboratory monitoring, and shipping of investigational products to study subjects.

209 -up, safety assessments, and continuation of investigational products, have included a shift to telem

210 In terms of development of new investigational products, the United States has followed

211 (68)Ga-DOTATOC and (68)Ga-PSMA-HBED-CC investigational radiopharmaceuticals are currently being

212 Trebananib, an investigational recombinant peptide-Fc fusion protein, n

213 vely map the landscape of resistance to this investigational regimen, we utilized a series of gain- a

214 ceptibility Testing (EUCAST) breakpoints and investigational (research-use-only) CLSI breakpoints exi

215 t, we discuss the development of ALN-GO1, an investigational RNA interference (RNAi) therapeutic targ

216 Fitusiran, an investigational RNA interference (RNAi) therapy that tar

217 Givosiran is an investigational RNA interference therapeutic agent that

218 silencing is the mechanism of lumasiran, an investigational RNA interference therapeutic for primary

219 The 3 formulations of the investigational RSV-PreF vaccine were well-tolerated and

220 entation has been demonstrated outside of an investigational setting to further confirm MSA as treatm

221 Patients, parents and caregivers, investigational site personnel, PTC Therapeutics employe

222 Investigational site staff, implanting physician, and st

223 sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular

224 ative Oncology Group performance status, and investigational site.

225 ctors: bone metastases; visceral metastases; investigational site; and prior abiraterone or enzalutam

226 phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres) in

227 CR-406/SARC021) at 81 academic or community investigational sites in 13 countries.

228 ody seropositive or seronegative NMOSD at 44 investigational sites in 13 countries.

229 omised, open-label, phase 3 study done at 21 investigational sites in China, South Korea, and Thailan

230 c medical disorders, were enrolled from four investigational sites in Colombia, Dominican Republic, G

231 In this phase 2 randomised study at 39 investigational sites in six countries, patients were ra

232 The study was performed at 50 investigational sites in the United States and 2 in Cana

233 s using the standard Spectralis tabletop and investigational Spectralis with Flex module devices, bot

234 le databases, we curated 883 FDA approved or investigational stage small molecule cancer drugs that t

235 baumannii complex for patient care until the investigational status has been removed from CLSI breakp

236 high-risk subset who should be targeted for investigational strategies other than standard ASCT.

237 d describe the current guidelines as well as investigational studies underway to improve the outcomes

238 s of transcranial magnetic stimulation (TMS) investigational studies.

239 hould be given to treating these patients in investigational studies.

240 ed on an institutional review board-approved investigational study of (11)C-methionine PET.

241 amplification, genes for which approved and investigational targeted therapies are available.

242 positive and negative agreements between the investigational test and the composite reference standar

243 to the subject infected status standard, the investigational test had sensitivity and specificity est

244 ensitivity and specificity estimates for the investigational tests in clinician-collected samples wer

245 sive supportive care measures, as well as an investigational therapeutic (TKM-100802) and convalescen

246 promotes antitumor immunity, highlighting an investigational therapeutic approach for some RAS pathwa

247 ggest that inhibition of SHP2 is a promising investigational therapeutic approach.

248 pose inadequacies in the conventional phased investigational therapeutic development paradigm.

249 d prognostic factors (CXCL10, CD4, CD3E) and investigational therapeutic targets (IL1A) for COVID-19.

250 management decisions and the development of investigational therapeutics are informed by an improved

251 he results of a randomized clinical trial of investigational therapeutics for EVD demonstrated surviv

252 brincidofovir, and/or convalescent plasma as investigational therapeutics.

253 empirical antibiotics; and 23 (85%) received investigational therapies (19 [70%] received at least tw

254 bility to determine the potential benefit of investigational therapies and the effect of patient-spec

255 Monoclonal and cellular investigational therapies are quite promising and should

256 ed cancer cells in PA, with implications for investigational therapies directed at this pathway.

257 nvasive monitoring, vasopressor support, and investigational therapies for Ebola virus disease.

258 We conducted a trial of four investigational therapies for EVD in the Democratic Repu

259 us accruing sites in a complex trial to test investigational therapies for moderately frequent molecu

260 The clinical activity of these newer investigational therapies has been mixed, with some ther

261 l trials are needed to delineate the role of investigational therapies in the care of patients with E

262 Investigational therapies under development for WM inclu

263 cting patient safety, facilitating access to investigational therapies, and ensuring trial integrity.

264 ide a rationale for the continued testing of investigational therapies, confirm the effectiveness of

265 2019), and medical treatment including four investigational therapies.

266 uville 4 should be the focus of risk-adapted investigational therapies.

267 agnosis and management of food allergies and investigational therapies.

268 tients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9

269 tudy evaluated the efficacy and safety of an investigational therapy for severe VKC, cyclosporine A (

270 The investigational therapy involved infusion of autologous

271 The investigational therapy involved infusion of autologous

272 nical trials for measuring the benefit of an investigational therapy on a patient's vision-related an

273 of study provisions that allow crossover to investigational therapy when benefit has been clearly de

274 anut oral immunotherapy (OIT) is a promising investigational therapy, its potential is limited by sub

275 l research; and 3) provided an unprecedented investigational tool to conduct longitudinal mechanistic

276 h the Aptima Mycoplasma genitalium assay, an investigational transcription-mediated amplification (TM

277 d at least one (partial or complete) dose of investigational treatment and who did not have any major

278 via a chimeric antigen receptor (CAR) is an investigational treatment capable of inducing complete t

279 d prompt temporary or permanent cessation of investigational treatment.

280 , and only 14% deemed possibly caused by the investigational treatment.

281 Investigational treatments on the basis of mechanistic a

282 cipation, and increase patient access to new investigational treatments.

283 uture peripheral artery disease cell therapy investigational trial design may be informed by new anat

284 ir with the MitraClip device in multicenter, investigational trials were included in this study.

285 fety, efficacy, and durability advantages of investigational triamcinolone acetonide suspension (CLS-

286 ty and immunogenicity of a second dose of an investigational trivalent CRM197-glycoconjugate GBS vacc

287 ty and immunogenicity of a second dose of an investigational trivalent CRM197-glycoconjugate GBS vacc

288 ed, observer-blind single-centre study of an investigational trivalent GBS vaccine in healthy non-pre

289 Despite promising pre-clinical data and investigational use in the clinic, relatively few drugs

290 n, we review clinical results reflecting the investigational use of CD19-targeted CAR T-cell therapeu

291 We performed a multicenter evaluation of the investigational use of the Carba-R assay for detection a

292 The GenMark Dx ePlex investigational use only blood culture identification fu

293 , including 2 FDA-cleared assays, 1 test for investigational use only, and 1 laboratory-developed tes

294 This multicenter study compared the investigational-use-only (IUO) BCID-GP Panel to other me

295 g, 2.5 mug, or 5.0 mug of the non-adjuvanted investigational vaccine (for each serotype), or placebo.

296 were randomly assigned (2:1) to receive the investigational vaccine (two injections, 1 month apart,

297 bo- and active-controlled study evaluated an investigational vaccine against RSV (ChAd155-RSV) using

298 serotype] of aluminium hydroxide-adjuvanted investigational vaccine) or placebo.

299 t possible to include known amounts of NA in investigational vaccines or to routinely measure NA cont

300 A multicenter study of the investigational Virtuo system (bioMerieux, Inc., Durham,