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1                            We gave treatment open label.
2 er day via single-dose dry-powder inhaler of open-label 18 mug tiotropium, patients were randomised (
3 n HIV-1 infected individuals (SWIFT-C) is an open-label, 2-cohort clinical trial in which the first c
4 se 4, multicenter, prospectively randomized, open-label, 24-week study comparing the incidence of pos
5                     A multicenter (5 sites), open-label, 9-month-duration, dose-ranging study was und
6                    This randomised, phase 3, open-label, active-controlled study was done at 46 sites
7 tients and Methods MATISSE was a randomized, open-label, adaptive phase III study.
8 he final analysis from GATSBY, a randomised, open-label, adaptive, phase 2/3 study, done at 107 centr
9 a blinded fashion for 12 months, followed by open-label alendronate in both groups.
10                                   During the open-label alendronate period, adjudicated events of ost
11 lic blood pressure (130-149mmHg vs <130mmHg; open label) and to antiplatelet treatment (aspirin/clopi
12 es >/=4 [moderate severity] at screening and open-label baseline).
13 inge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions-Severit
14 er, parallel-group, prospective, randomized, open-label, blinded end point trial, consenting patients
15 cularization (ASTER) study was a randomized, open-label, blinded end-point clinical trial conducted i
16 d an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants
17 is multicentre, parallel group, superiority, open-label, blinded-endpoint, randomised controlled tria
18                     Treatment allocation was open label but endpoints at 12 months were assessed by m
19       The recommended doses of warfarin were open label, but the patients and clinicians were blinded
20                                Treatment was open-label, but investigators assessing primary efficacy
21 intravenously or placebo in combination with open-label chemotherapy (epirubicin 50 mg/m(2) intraveno
22                    A single-site prospective open-label clinical study with cyclotron-produced sodium
23              This international, randomized, open-label clinical trial (EUROMAX [European Ambulance A
24          METHODS AND This was a prospective, open-label clinical trial in 50 patients with coronary a
25                               Nonrandomized, open-label clinical trial initiated in 2015.
26 ucted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Ang
27 re enrolled in this randomized, multicenter, open-label clinical trial, and randomly assigned to RSL
28               In a proof of concept, 6-week, open-label clinical trial, intranasal theophylline (an e
29 his multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with eit
30 hase 3, randomized, controlled, multicenter, open-label clinical trial.
31         Part B of these randomised, phase 2, open-label clinical trials enrolled individuals from 15
32 A of these phase 2, randomised, multicentre, open-label, clinical trials enrolled participants from 1
33                                    We did an open-label cluster-randomised trial in villages in the M
34                            We did a phase 4, open-label, cluster randomised trial of 22 communities i
35                                         This open-label, cluster, crossover trial was done in two Gha
36                                    We did an open-label, cluster-randomised ring vaccination trial (E
37                                  We did this open-label, cluster-randomised trial (DiRECT) at 49 prim
38                        INTERPRETATION: In an open-label cohort of limited size, brexanolone demonstra
39                 In a prospective multicenter open-label cohort study, 342 patients with abdominal aor
40 ients underwent surgery for DBS and received open-label continuous stimulation for the entire 1 year
41                                              Open-label crossover randomized clinical trial conducted
42                                     After an open-label dose-escalation study in a pilot safety cohor
43                          This was a phase 1, open-label, dose-escalating study done at four outpatien
44                                  This was an open-label, dose-escalation phase 1 trial done at two st
45                       In this single-centre, open-label, dose-escalation phase 1 trial, we recruited
46                                      In this open-label, dose-escalation phase 1-2a study, we gave mo
47                               This phase 1b, open-label, dose-escalation study assessed the safety, e
48                     Phase 1/2a, multicenter, open-label, dose-escalation, fellow-eye-controlled study
49                In this phase 2, multicentre, open-label, dose-finding study (PACE-MDS), with long-ter
50                       ASPIRE consisted of an open-label, double-blind phase for 8 weeks and a randomi
51           The ReSource Project was a 9-month open-label efficacy trial of three, 3-month secularized
52                                       In the open-label ELEVATE trial, kidney transplant patients wer
53 e open-label phase (-126.3 minutes at 1-year open-label end point).
54 r being in prison during the 3 months before open-label enrolment were more likely to return for at l
55 erapy Trial (SATT), a three-arm, randomised, open-label, equivalence trial in five communities in Kar
56 ives included pharmacokinetic assessment and open-label evaluation of brexanolone response during and
57 as a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover
58                                          The open-label EXTEND study evaluated long-term safety and e
59  controlled study involving 186 patients; an open label extension study performed after the phase 3.
60 (6-55 years) from 22 centers, with a 2-year, open-label extension (July 31, 2012-July 31, 2014; exten
61 egrated parent trials) and the first year of open-label extension (OLE) trials that included a standa
62 1 and 2, reported here) for 12 weeks, and an open-label extension (part 3).
63 k period could also participate in an 8-week open-label extension period.
64             Follow-up of patients during the open-label extension revealed no new safety signals and
65                       Phase IV, multicenter, open-label extension study.
66                     This ongoing, randomized open-label extension trial (OSLER-1) was conducted at 19
67 RAPID-RCT trial were included in this 2-year open-label extension trial (RAPID-OLE).
68                                        In an open-label extension, 115 patients subsequently received
69  were more likely to return for at least one open-label follow-up visit than those who did not report
70  injected midazolam or were in prison during open-label follow-up were more likely to be greater than
71 an interim database lock at week 16, and was open label from week 16 onwards, with no masking of part
72  treatment failure from the run-in period of open-label inhaled fluticasone, and the treatment period
73 as a phase-3, randomised, active-controlled, open-label, international, multicentre trial, done at 10
74                          In this randomised, open-label, international, phase 3 trial, men with radio
75                    Both groups could receive open-label LAI for 84 additional days.
76                                      In this open-label, masked endpoint, randomised, non-inferiority
77                            Patients received open-label MEDI2070 (210 mg) subcutaneously every 4 week
78 andomly assigned (2:1) to either 24 weeks of open-label momelotinib 200 mg once a day or BAT (which c
79                                      In this open label, multicenter study conducted over 1-year foll
80                              Methods In this open-label, multicenter (n = 13), parallel-arm, phase II
81                                  Single-arm, open-label, multicenter clinical study.
82 d C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies.
83                                        In an open-label, multicenter study, adults >/=65 years of age
84                     This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usu
85                                      In this open-label, multicenter trial with crossover design, we
86                In a randomized, prospective, open-label, multicenter trial, 48 patients with severe C
87                   Patients and Methods In an open-label, multicenter trial, patients were randomly as
88 VEYOR-II, Part 3 was a partially randomized, open-label, multicenter, phase 3 study.
89                We conducted a nonrandomized, open-label, multicenter, phase 4 study.
90 Methods This was a single-arm, single-stage, open-label, multicenter, phase II trial.
91                      We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Bel
92              The ARIA study is a randomised, open-label, multicentre, active-controlled, parallel-gro
93                               This phase 1b, open-label, multicentre, dose-escalation study was done
94                                         This open-label, multicentre, phase 1 study was undertaken at
95                          In this randomised, open-label, multicentre, phase 2 trial, 29 academic medi
96                 We did a phase 3, two-group, open-label, multicentre, randomised clinical trial at 92
97  6 APDS patients was conducted as a 12-week, open-label, multisite, within-subject, dose-escalation s
98                   Limitations: The study was open label, no inferential statistics were planned, and
99                          We did a phase 1/2, open-label, non-comparative, dose escalation and expansi
100           We did a multicentre, prospective, open-label, non-inferiority randomised clinical trial (S
101                         We did a randomised, open-label, non-inferiority, parallel-group, multicentre
102 amilial hypercholesterolaemia enrolled in an open-label, non-randomised phase 3 trial.
103                                      In this open-label, non-randomised, phase 2 trial, patients aged
104                    Multicenter, prospective, open label, noncomparative, interventional study.
105                      This was a multicenter, open-label, noninferiority trial (margin 12%).
106                                      In this open-label, noninferiority trial, we randomly assigned 4
107                         In this multicenter, open-label, noninferiority trial, we randomly assigned 5
108                                      In this open-label, noninferiority trial, we randomly assigned p
109 DS enrolled in the prospective, multicenter, open-label, nonrandomized ML-DS 2006 trial by Nordic Soc
110            METHOD: This 5-year, prospective, open-label, nonrandomized, observational registry study
111 e frequently with cumulative exposure during open-label observation.
112 idate our hypothesis in a phase 2 randomized open-label parallel-group study in male and female patie
113                                          The open-label, parallel-cohort, dose-escalation, phase I Ch
114                             This randomized, open-label, parallel-group study included patients aged
115                      For this single-centre, open-label, parallel-group, randomised controlled trial,
116                                          The open-label part A was conducted in the United States, fo
117 rial consisting of an initial 12- to 16-week open-label period and a 26-week double-blind randomized
118 akathisia (7.7%), and sedation (7.7%) in the open-label period and mania (11.9% of the placebo group
119 get asenapine dosage was 10 mg b.i.d. in the open-label period but could be titrated down to 5 mg b.i
120          A total of 549 subjects entered the open-label period, of whom 253 enrolled in the double-bl
121                         After completing the open-label period, subjects meeting stabilization/stable
122 -time reduction was sustained throughout the open-label phase (-126.3 minutes at 1-year open-label en
123                         Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfe
124 ost common adverse event with BIIB074 in the open-label phase (in 13 [19%] of 67 patients), followed
125                                      In this open-label phase 1 dose-escalation study conducted at Ba
126             In this multicentre, randomised, open-label phase 2-3 trial, we recruited patients aged 1
127                         We did a randomised, open-label phase 3 KRISTINE trial in 68 Translational Re
128          SABRINA is a two-stage, randomised, open-label phase 3 study at 113 centres in 30 countries.
129              NEMO is an ongoing, randomised, open-label phase 3 study done at 118 hospitals in 26 cou
130                                        In an open-label phase 3 trial, we compared first-line nivolum
131                                          The open-label phase focused on maintenance of treatment eff
132                    Patients and Methods This open-label phase II study enrolled adults with Ph(+) ALL
133   Patients and Methods This randomized (1:1) open-label phase II trial compared the efficacy of pazop
134                                      In this open-label phase III trial, we evaluated the safety, tol
135      Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; m
136 injections for 7 days, followed by a 16-week open-label phase with canakinumab injections on confirme
137 leted the double-blind phase and entered the open-label phase, of whom 286 completed 1 year of open-l
138 ed experience of two independently performed open-label, phase 1-2 trials (conducted in Sweden and th
139            We did a multicentre, randomised, open-label, phase 1/2 study of guadecitabine in cohorts
140                                    We did an open-label, phase 1/2 trial at the National Taiwan Unive
141 as part of the non-randomised, multi-cohort, open-label, phase 1b KEYNOTE-012 basket trial.
142                                      In this open-label, phase 1b trial, we recruited patients from 1
143                         We did a randomised, open-label, phase 2 clinical trial (HPTN 067/ADAPT) of o
144                                  We did this open-label, phase 2 study at 11 hospitals in the USA and
145      This ongoing, multicentre, multicohort, open-label, phase 2 study evaluated oral dabrafenib (150
146                  We conducted a multicenter, open-label, phase 2 study to evaluate the efficacy and s
147                                      In this open-label, phase 2 study, oral acalabrutinib (100 mg tw
148              In this two-cohort, single-arm, open-label, phase 2 study, we enrolled patients with sof
149                         In this multicenter, open-label, phase 2 study, we evaluated the efficacy and
150  was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 ye
151 ficacy and safety data from a single-centre, open-label, phase 2 trial, after a median of 83 months f
152                In this ongoing, multicentre, open-label, phase 2 trial, we enrolled adults (aged >/=1
153                   We did this single-centre, open-label, phase 2, multicohort study in the USA.
154 did an international, randomised, multi-arm, open-label, phase 3 cooperative group clinical trial of
155               We conducted this multicentre, open-label, phase 3 randomised controlled trial (IMvigor
156 (BIG 1-01) is an international, multicentre, open-label, phase 3 randomised trial of 5102 women with
157                                  We did this open-label, phase 3 study (SWOG S0819) at 277 sites in t
158               Kids B-LONG was a multicentre, open-label, phase 3 study assessing the safety, efficacy
159                             This randomised, open-label, phase 3 study in untreated patients with sta
160      EMILIA was a randomised, international, open-label, phase 3 study of men and women aged 18 years
161 this international, multicentre, randomised, open-label, phase 3 study, we enrolled adults (aged >/=1
162      In the randomised, parallel assignment, open-label, phase 3 TH3RESA study, progression-free surv
163                         We did a randomised, open-label, phase 3 trial (OAK) in 194 academic or commu
164              CheckMate 141 was a randomised, open-label, phase 3 trial in patients with recurrent or
165      ACCL0431 was a multicentre, randomised, open-label, phase 3 trial that enrolled participants at
166                  We conducted a multicenter, open-label, phase 3 trial to evaluate the efficacy and s
167              In this randomised, controlled, open-label, phase 3 trial, we recruited patients aged at
168              In this randomised, controlled, open-label, phase 3 trial, we recruited patients with me
169                          In this randomised, open-label, phase 3 trial, we recruited patients with ne
170 this multicentre, international, randomised, open-label, phase 3 trial, we recruited patients with tr
171                                      In this open-label, phase 3, multicentre, international study, a
172                     The CONVERT trial was an open-label, phase 3, randomised superiority trial.
173                  RESPONSE-2 is a randomised, open-label, phase 3b study assessing ruxolitinib versus
174                                           An open-label, phase 4 randomized clinical trial designed a
175  was a prospective, randomized, multicenter, open-label, phase III noninferiority trial.
176    Patients and Methods In this multicenter, open-label, phase III trial, 2,012 women with early TOP2
177 tudy drug dosing during the double-blind and open-label phases, respectively.
178 he 1315 eligible participants chose to start open-label PrEP and were followed up for a median of 335
179                              We performed an open-label, prospective, multicenter study of the effect
180                         Methods MITO-8 is an open-label, prospective, randomized, superiority trial.
181 nstitutions in 18 countries that included an open-label randomised arm in which high-dose chemotherap
182                    METHODS AND Compass is an open-label randomised trial of 5-yearly HPV screening ve
183                         In this multicentre, open-label randomised trial, 102 hospitals (Australia [t
184                                      In this open-label, randomised contolled trial, we recruited chi
185 Appendicectomy (CHINA) study, a multicentre, open-label, randomised controlled study at 19 specialist
186                      ENDEAVOR was a phase 3, open-label, randomised controlled trial in patients with
187             We did a pragmatic, multicentre, open-label, randomised controlled trial in seven HIV cli
188               We undertook this multicentre, open-label, randomised controlled trial in two public ho
189           In this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adu
190                         In this multicentre, open-label, randomised controlled trial, we recruited wo
191                      We did two prospective, open-label, randomised controlled trials assessing iron
192                   We initiated this 24 week, open-label, randomised controlled, comparative effective
193                             The multicentre, open-label, randomised phase 3 GOG-0213 trial was done i
194 analysis of additional data from a published open-label, randomised trial of second-line ART (EARNEST
195                                  CALM was an open-label, randomised, controlled phase 3 study, done i
196                                      In this open-label, randomised, controlled phase 3 trial done at
197                              In this global, open-label, randomised, controlled phase 3 trial, we enr
198 uded patients enrolled in the international, open-label, randomised, controlled, phase 3 AZURE trial
199                                    We did an open-label, randomised, controlled, two-arm effectivenes
200                      We did the multicentre, open-label, randomised, parallel, phase 3 SOLE trial in
201                                     For this open-label, randomised, phase 2 selection design trial o
202                  tAnGo was an international, open-label, randomised, phase 3 superiority trial that e
203                                    We did an open-label, randomised, phase 3 trial of adult patients
204                         In this multicentre, open-label, randomised, phase 3 trial, we recruited pati
205                       In this international, open-label, randomised, phase 3, multicentre trial, we e
206                         This was a bicentre, open-label, randomised, three-arm phase 3 trial done in
207                              We conducted an open-label randomized clinical trial to compare the effi
208          A 12-week, multicenter, outpatient, open-label randomized clinical trial was conducted at 5
209 ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial of adju
210 ves birth weight.We performed a multicenter, open-label randomized controlled trial [Maternal and Off
211                                        In an open-label randomized crossover study, 19 healthy firefi
212                              Purpose Several open-label randomized studies have suggested that in viv
213            The design of the study was as an open labeled, randomized, one treatment, one period, sin
214                                  This was an open-label, randomized (1:1) study (ROPETAR trial).
215 accine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged >/=
216                                           An open-label, randomized clinical trial with a 5-month fol
217 on, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a b
218                              We conducted an open-label, randomized, controlled trial to assess the d
219 lanyl-glutamine (AlaGln) in 6 patients in an open-label, randomized, crossover pilot trial (EudraCT 2
220  = 16) underwent 4 weeks of sham followed by open-label rTMS for nonresponders (n = 12).
221                STOP-Uveitis is a randomized, open-label safety, efficacy, and bioactivity clinical tr
222                                              Open-label, safety and efficacy study in patients with H
223                           We did a parallel, open-label single-center randomized controlled trial at
224 e studies had moderate risk of bias (10 were open-label single-group trials, 11 had limited informati
225           Pragmatic, investigator initiated, open label, single site, randomized clinical trial.
226                                      In this open-label, single group, multicentre phase 2 trial, we
227                            We did a phase 2, open-label, single-arm study at six centres (hospitals a
228 D A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting
229                             In this ongoing, open-label, single-arm study that started on December 21
230                                         This open-label, single-arm trial, done in Germany and the UK
231           In this international multicentre, open-label, single-arm, first-in-man phase 1 dose-escala
232                        We did a multicentre, open-label, single-arm, phase 3b study (GARNET) in 20 ho
233                               C-SWIFT was an open-label, single-center trial in treatment-naive patie
234                                         This open-label, single-centre, phase 1a, dose-escalation tri
235                                      In this open-label, single-group assignment study, with median f
236 nders and 5 were remitters after 6 months of open-label stimulation.
237 lable controlled trials, was integrated with open-label studies and case series, along with the exper
238                                     Previous open-label studies have shown lower day-to-day variabili
239                            In nonrandomized, open-label studies, a transcatheter interatrial shunt de
240  were pooled from four large, observational, open-label studies: STRATIFY-2, STRATA, TOP, and TYGRIS.
241 isense oligonucleotide targeting exon 51: an open label study including 12 patients; a phase 3 random
242 ilization in the 12 patients involved in the open label study.
243                                This phase 2, open-label study (MAGELLAN-1) evaluated the efficacy and
244                                  A Phase 2a, open-label study (NCT01724086) was conducted to assess t
245                       We conducted a phase 1 open-label study at ten cancer centres in the USA.
246                                  This was an open-label study conducted in the 2012-2013 influenza se
247 ternational, multicentre, two-part, phase 2, open-label study done at 49 hospitals and cancer centres
248                Twenty-five patients received open-label study drug.
249                            This multicenter, open-label study evaluated the safety and efficacy of ib
250                   We conducted a single-arm, open-label study in which 15 virologically suppressed HI
251                          This multinational, open-label study included 10 adults with hemophilia B (F
252                                This Phase 2, open-label study included 2 cohorts in New Zealand.
253 S Clinical Trials Group A5175, a randomized, open-label study of 3 ART regimens among 1571 participan
254                                          The Open-Label Study of Long-term Evaluation Against LDL-C (
255 ere randomly assigned (2:1) to switch to the open-label study regimen or continue the control regimen
256     We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous
257         We conducted a phase 2, multicenter, open-label study to evaluate the efficacy and safety of
258                              The aim of this open-label study was to assess whether this dietary supp
259              This was a phase 3, randomised, open-label study with a 2 x 2 factorial design.
260 n limitation of this study is that it was an open-label study with an observed-only control group (no
261 ontrolled study for 16 weeks, followed by an open-label study with overall 40-week DHA treatment.
262 d, multicohort, multicentre, non-randomised, open-label study, adults (>/=18 years of age) with previ
263                In this randomised, phase 2b, open-label study, treatment-naive adults infected with H
264 acrolimus (TacHexal) or Prograf in a 6-month open-label study.
265 c fibrosis homozygous for F508del-CFTR in an open-label study.
266 er were enrolled with intent to treat in the open-label study; 36 completed treatment, had useable da
267  active or sham DBS, followed by 6 months of open-label subcallosal cingulate DBS.
268  oral semaglutide with placebo (primary) and open-label subcutaneous semaglutide (secondary) on glyce
269                            This multicentre, open-label substudy was done at 19 sites in seven countr
270              In this randomised, controlled, open-label, superiority study, we recruited hospitalised
271  behavioral intervention in conjunction with open-label TDF/FTC.
272 e trial, participants were offered 1 year of open-label tenofovir.
273  HRSD17 of 7 following 8 weeks of randomized open-label treatment ADMs: escitalopram, sertraline or v
274                   The sham group was offered open-label treatment after unblinding.
275 ssigned (1:1:1:1) with a block size of 4, to open-label treatment to one of four treatment groups: gr
276 er, prospective, randomized, parallel-group, open-label treatment trial with a blinded end-point eval
277 ients were randomized to receive 24 weeks of open-label treatment with either 6 or 18 mg of selonsert
278 label phase, of whom 286 completed 1 year of open-label treatment.
279                            In this factorial open-label trial conducted in Uganda, Zimbabwe, Malawi,
280 ults of a multicenter, phase III, randomized open-label trial exploring the benefit of adding androge
281                                      A pilot open-label trial of arbaclofen suggested similar benefit
282                              We conducted an open-label trial to evaluate the safety, tolerability, a
283                    A randomized, controlled, open-label trial was conducted.
284                               For part 2, an open-label trial was done in which previously vaccinated
285              We did a randomised controlled, open-label trial with a multi-arm, multi-stage design.
286                        Here, we conducted an open-label trial with PfSPZ Vaccine at a dose of 9.0 x 1
287               In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary
288               In a phase 2/3, single-center, open-label trial, participants from Ontario, Canada, exp
289                 In this randomised, phase 3, open-label trial, patients were screened for eligibility
290                          In this single-arm, open-label trial, we enrolled virologically suppressed,
291                In a multicenter, randomized, open-label trial, with blinded adjudication of end-point
292              We did two phase 1, randomised, open-label trials involving healthy adult volunteers.
293 gmatic, multicenter, randomized, controlled, open-label trials with blinded outcome evaluation: the P
294                                In 2 phase 3, open-label trials, patients with HCV infection who had n
295                                  Among the 6 open-label (unblinded) studies, we found that pacing was
296                                     Phase 1, open-label, uncontrolled, dose-escalation study at 5 US
297                                    We did an open-label, uncontrolled, prospective, phase 1 clinical
298                                  Prospective open-label, unilateral single-dose, intravitreal injecti
299 cipants received protocolized treatment with open-label venlafaxine, up to 300 mg/day for approximate
300           Allocation to cohort 1A and 1B was open-label, within cohorts 1A and 2, allocation to DSM26

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