ライフサイエンスコーパス: investigational

1 ction, followed by concomitant treatment, is investigational.

2 s with advanced biliary tract cancer remains investigational.

3 controversial and in general, should remain investigational.

4 e of antiangiogenic therapy in mCRPC remains investigational.

5 ic treatment of nongastric lymphomas remains investigational.

6 The investigational 9-valent viruslike particle vaccine agai

7 ple size requirements for clinical trials of investigational AD-modifying therapies, and provide stra

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

9 nhibitor-free protocol inclusive of a single investigational agent for use in clinical islet transpla

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

11 ce, selective p110alpha inhibition using the investigational agent MLN1117 (previously known as INK11

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

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

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

15 nsent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance a

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

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

18 CL01, which is the first human study of this investigational agent.

19 Investigational agents are not likely to provide an alte

20 suppression with use of better-tolerated and investigational agents for unfit patients and those with

21 of the disease have opened the door to study investigational agents that target disrupted molecular p

22 Several investigational agents with activity against drug-resist

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

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

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

26 vaccinia immune globulin and who received 2 investigational agents, ST-246 and CMX001.

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

28 low minimum inhibitory concentrations of an investigational aminoglycoside, belonged to multi-locus

29 SBT is no longer considered investigational and given improved outcomes noted in rec

30 ty preservation methods should be considered investigational and should be performed by providers wit

31 ets, is important for planning and analyzing investigational and therapeutic interventions in many bi

32 p120 and were cross-resistant to TAK-779, an investigational antagonist, and maraviroc (MVC).

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

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

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

36 sted the hypothesis that encapsulation of an investigational anti-PAH molecule fasudil (HA-1077), a R

37 AZD1305 is an investigational antiarrhythmic agent for management of a

38 evaluating the addition of iniparib, a novel investigational anticancer agent that does not possess c

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

40 o)gallium(III) (1, KP46) is a very promising investigational anticancer drug.

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

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

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

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

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

46 at can be used for a variety of clinical and investigational applications not previously possible.

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

48 hibition continues to expand to a variety of investigational arenas.

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

50 igm relies on randomized comparisons between investigational arms and control arms, as historical con

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

52 hat have been used to date, and consider new investigational avenues that might accelerate clinically

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

54 n B-precursor ALL and can be targeted by the investigational bispecific T cell-engager antibody blina

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

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

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

58 ed 2 vaccine doses (days 0 and 21) of either investigational CC-H5N1 vaccine (1.9 microg or 3.75 micr

59 developed resistance to vicriviroc (VCV), an investigational CCR5 antagonist, during 28 weeks of ther

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

61 cebo-controlled, parallel-group trial at 106 investigational centres in the Americas, Australia, Euro

62 ed combination treatment with lumacaftor, an investigational CFTR corrector that increases traffickin

63 VX-809 is an investigational CFTR corrector that partially restores C

64 lerosis, provide an overview of clinical and investigational characteristics of each disorder, and pr

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

66 ted to the nine clinical trials in which the investigational chemotherapeutic arm demonstrated benefi

67 The investigational cigarettes had nicotine content ranging

68 l brand of cigarettes or one of six types of investigational cigarettes, provided free.

69 specimens were imaged intraoperatively in an investigational CLI system.

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

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

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

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

74 This investigational compound is currently in phase 1 clinica

75 stemological gradient that should also be an investigational continuum.

76 -CFTR cellular stability and the efficacy of investigational correctors, including 3-(6-[([1-(2,2-dif

77 Previously uncharacterized investigational covalent drugs reported here are shown t

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

79 t-of-care tests, efficacy of recommended and investigational CT infection treatments, and timing of t

80 ed in previous studies of one or more Gilead investigational DAAs in combination with RBV with or wit

81 rus infections with available (ribavirin) or investigational (DAS181) antiviral agents still needs to

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

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

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

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

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

87 The US Investigational Device Exemption trial prospectively enr

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

89 y-of-life outcomes and adverse events in the investigational device group.

90 ctive consecutive case series regarding this investigational device.

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

92 ological response (SVR) after treatment with investigational direct-acting antiviral agents (DAAs) ha

93 n controversial in monitoring the effects of investigational disease-modifying drugs.

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

95 research on adherence to placebo-controlled investigational drug by way of drug detection in active-

96 ne-3-carboxamide (VX-770, 48, ivacaftor), an investigational drug candidate approved by the FDA for t

97 asma concentration-time results of NVP-1, an investigational drug candidate, observed in the plasma s

98 Eritoran is an investigational drug for sepsis treatment that resembles

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

100 ifies an apoptotic biomarker (PYCARD) for an investigational drug obatoclax.

101 Task Force of the National Cancer Institute Investigational Drug Steering Committee convened an inte

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

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

104 ity defect can be partially corrected by the investigational drug VX-809 (3-[6-[[[1-(2,2-difluoro-1,3

105 at several of these compounds, including the investigational drug VX-809, caused a much greater incre

106 ue and displayed an additive effect with the investigational drug VX-809.

107 This investigational drug was compared with the common antihy

108 The investigational drug, nivolumab, was administered intrav

109 nd some of the limitations of this important investigational drug, these findings clearly demonstrate

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

111 ntral fat accumulation were recorded for the investigational drug.

112 s new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of

113 Currently only investigational drugs are available in case of radiologi

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

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

116 r (VEGF) therapy and ionizing radiation, and investigational drugs that address different targets alo

117 ents, has led to the clinical development of investigational drugs that restore function to defective

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

119 ng to abandonment of potentially efficacious investigational drugs, and unexpected deadly adverse eve

120 F-FDG PET for guiding the selection of novel investigational drugs, choosing dose in early-phase clin

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

122 For both investigational drugs, PET responses tended to be greate

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

124 o as to improve the efficacy of approved and investigational drugs.

125 The investigational Ebolavirus and Marburgvirus WT GP DNA va

126 a rationale for increased basic and clinical investigational efforts to further understand Lp(a) path

127 in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 mon

128 hese data establish that sebelipase alfa, an investigational enzyme replacement, in patients with CES

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

130 Elesclomol, an investigational first-in-class compound, induces oxidati

131 Clinically active investigational FLT3 inhibitors can achieve complete rem

132 nt years, there has been a shift in clinical investigational focus toward refinements in the methods

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

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

135 Our results suggest that licensed and investigational HPV prophylactic vaccines have the poten

136 ography have enabled recent translation into investigational human studies.

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

138 valuated the immunogenicity and safety of an investigational HZ subunit vaccine (HZ/su).

139 B via an implanted drug infusion pump and an investigational i.c.v. catheter.

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

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

142 resistance to AC220 (quizartinib), an active investigational inhibitor of FLT3, KIT, PDGFRA, PDGFRB a

143 itor amprenavir (1) and two potent antiviral investigational inhibitors GRL-02031 (2) and GRL-0519 (3

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

145 A(H1N1)pdm09 (pH1N1) pandemic, peramivir, an investigational intravenous neuraminidase inhibitor, was

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

147 We highlight the investigational journey from patient phenotype to treatm

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

149 Concordance of investigational methods with automated extraction was >/

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

151 toxicities associated with both approved and investigational molecularly targeted agents.

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 All patients were informed about the investigational nature of the procedures and provided wr

155 ations in the lymphatic system, we performed investigational near-infrared fluorescence lymphatic ima

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

157 prescribers of FMT must possess an approved investigational new drug (IND) permit to administer FMT

158 given to at-risk laboratory personnel as an investigational new drug (IND).

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

160 ld-type influenza A challenge study under an Investigational New Drug application (IND).

161 Imaging was performed under a physician's Investigational New Drug application from the Food and D

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

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

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

165 Conducted under an investigational new drug authorization, we prospectively

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

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

168 and led to the selection of LFF571 (4) as an investigational new drug for treating C. difficile infec

169 The exploratory investigational new drug guidance describes early phase

170 Currently, this investigational new drug is under clinical development f

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

172 e desirable.OBSERVATIONS A compassionate-use investigational new drug protocol was approved to admini

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

174 Under an exploratory investigational new drug, using a cross-over design, we

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

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

177 tribution of the individual components of an investigational non-beta-antagonist fixed combination of

178 genic HPV16/18/31/33/45/52/58 targeted by an investigational nonavalent HPV vaccine ranged from 39% t

179 oral avatrombopag (2.5, 5, 10, or 20 mg), an investigational nonpeptide TPO-RA active in humans, or p

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

181 s of this review are to discuss standard and investigational nontransplant treatment strategies for a

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

183 MK-5172 is an investigational once-daily protease inhibitor.

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 Ixazomib is the first investigational oral proteasome inhibitor to be studied

187 Ixazomib is an investigational, oral, proteasome inhibitor with promisi

188 Alisertib is an investigational, oral, selective inhibitor of aurora kin

189 Ixazomib is an investigational, orally bioavailable 20S proteasome inhi

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

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

192 ar endothelial growth factor) throughout the investigational period.

193 re used to model amyloid deposition with the investigational PET imaging agent (18)F-flutemetamol.

194 (68)Ga-DOTATATE is an investigational PET/CT imaging agent that binds with hig

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

196 The patient was enrolled onto an investigational phase II study; however, she developed p

197 vel framework for physiology programs and an investigational platform for physiologists to study func

198 Here, we report the development of an investigational platform that positions tumor cells next

199 nically well-tolerated, orally bioavailable, investigational prodrug that delivers to the brain BCI-6

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

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

202 Of 168 patients randomized, 167 received investigational product and were included in the full an

203 s in the bromfenac group (3.2%) discontinued investigational product early because of a lack of effic

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

205 ized subjects receiving one or more doses of investigational product using last-observation-carried-f

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

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

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

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

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

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

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

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

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

215 p shorter-term end points for trials testing investigational products or regimens for second-line sys

216 We tested the efficacy of an investigational proteasome inhibitor, ixazomib, alone an

217 rols, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin

218 Success occurred in 90.7% of investigational pump patients and 90.1% of controls, est

219 The course of investigational pump recipients was compared with that o

220 A total of 140 patients received the investigational pump, and 499 patients received a commer

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

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

223 We compared the performance of two automated investigational/research use only (IUO/RUO) NAATs for th

224 This study was approved by the investigational review board and was compliant with the

225 Investigational review board approval was obtained for t

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

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

228 our results suggest that phase II obatoclax, investigational SaliPhe, and FDA/EMEA-approved gemcitabi

229 Oritavancin is an investigational semisynthetic glycopeptide with potent i

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

231 ative Oncology Group performance status, and investigational site.

232 Feb 12 and July 30, 2010, 173 patients at 43 investigational sites in 12 countries were enrolled into

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

234 ndomised, double-blind, phase 3 trial at 169 investigational sites in 24 countries.

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

236 s with chronic HCV infection treated at four investigational sites in Germany.

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

238 MLN4924 is an investigational small molecule currently in phase I clin

239 Finally, MLN4924, an investigational small molecule inhibitor of NEDD8-activa

240 e during treatment with vicriviroc (VCV), an investigational small-molecule CCR5 antagonist.

241 MLN4924 is an investigational small-molecule inhibitor of NEDD8-activa

242 MLN4924 is an investigational small-molecule inhibitor of the NEDD8-ac

243 MLN8237, an investigational small-molecule selective inhibitor of AU

244 or behavioural disorder, still remains at an investigational stage.

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

246 ts the causes underlying such deaths and the investigational strategies that identify surviving famil

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

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

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

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

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

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

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

258 gnaling are reviewed along with an update on investigational therapies that use this pathway to rever

259 Investigational therapies under development for WM inclu

260 onsultation, options for standard as well as investigational therapies were discussed, and HLA typing

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

262 e relative contributions of supportive care, investigational therapies, and patient's immune-response

263 an papillomavirus-negative HNSCC, as well as investigational therapies, such as hypoxia modification,

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

265 agnosis and management of food allergies and investigational therapies.

266 ir potential to be targeted with approved or investigational therapies.

267 changes as shown by the mfVEP in response to investigational therapies.

268 The investigational therapy involved infusion of autologous

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

270 consent for a trial but before receiving the investigational therapy, participants answered questions

271 ted virus vectors also represent outstanding investigational tools to explore the function of individ

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

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

274 deep brain stimulation (DBS) is an evolving investigational treatment for depression.

275 ave efficacy as an off-the-shelf therapy for investigational treatment of B-lineage malignancies.

276 rative Colitis Research Studies Utilizing an Investigational Treatment, eg, PURSUIT).

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

278 Investigational treatments on the basis of mechanistic a

279 We will also review several investigational treatments that have shown promise for t

280 e include evolving treatment strategies, new investigational treatments, and earlier implementation o

281 treatment options and treatment strategies, investigational treatments, and the importance of exerci

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

286 oped tuberculosis in a phase III trial of an investigational tuberculosis vaccine, greater baseline I

287 Here we demonstrate that the investigational type I TKI crenolanib is a potent inhibi

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

289 We evaluated the investigational use only (IUO) version of the rapid Veri

290 blood culture (BC-GP) nucleic acid test for investigational use only (Nanosphere, Inc., Northbrook,

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

292 intended to give an overview of the current investigational uses of OCT and its potential roles as t

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

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

295 of HSV-1- and HSV-2-seronegative women, the investigational vaccine was effective in preventing HSV-

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

297 nths 0, 1, and 6, some subjects received the investigational vaccine, consisting of 20 mug of glycopr

298 was most consistent among recipients of the investigational vaccine.

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

300 had initially received placebo were offered investigational zoster vaccine without charge.